| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00872320005634 | 001-00107 | Large laser protective glasses for use with the Monet Curing Laser. | QNF | Laser Activator For Polymerization | 2 | Monet Curing Laser Large Glasses | |
| 2 | 00872320005610 | 001-00105 | Handheld laser device used for polymerizing dental materials. | QNF | Laser Activator For Polymerization | 2 | Monet Curing Laser | |
| 3 | 00872320005948 | 04862 | Single-use barrier sleeve for use with the Monet Curing Laser. | QNF | Laser Activator For Polymerization | Monet Curing Laser Barrier Sleeve | ||
| 4 | 00872320004392 | 01808 | Single-use leur-lock dental applicator brush. | KXR | Applicator, Resin | Visco Tip | ||
| 5 | 00872320004385 | 01807 | Single-use luer-lock dental applicator brush. | KXR | Applicator, Resin | Liqua Tip | ||
| 6 | 00872320004378 | 01859 | Single use flocked-fiber luer-lock applicator tip. | KXR | Applicator, Resin | FE Scrub Tip | ||
| 7 | 00872320004279 | SF400-PLUS | Strippable optical fiber cable for use with the Picasso Lite Plus and Picasso Pl Strippable optical fiber cable for use with the Picasso Lite Plus and Picasso Plus diode lasers. | GEX | Powered Laser Surgical Instrument | 2 | Picasso Plus Strippable Fiber Cable | |
| 8 | 00872320003487 | 002-00267 | 002-00267 | Laser protective eyewear for use with the Precise family of diode lasers. | GEX | Powered Laser Surgical Instrument | 2 | Precise Laser Sport-Style Glasses |
| 9 | 00872320003388 | 00668 | Single-use straight tip for use with the Pioneer Pro Diode Laser. | GEX | Powered Laser Surgical Instrument | Pioneer Pro Straight Tip | ||
| 10 | 00872320003272 | 006-00114 | 006-00114 | Single-use sample pack of FastFix dental porcelain primer. | KLE | Agent, Tooth Bonding, Resin | 2 | FastFix Sample Pack |
| 11 | 00872320003234 | 002-00252 | 002-00252 | Removable therapy handpiece sleeve for use with the Precise SHP Diode Laser. | GEX | Powered Laser Surgical Instrument | 2 | Precise SHP Therapy Handpiece Sleeve |
| 12 | 00872320002541 | 002-00247 | 002-00247 | Replacement wireless footswitch for use with the Pioneer Pro Diode Laser. | GEX | Powered Laser Surgical Instrument | 2 | Pioneer Pro Wireless Footswitch |
| 13 | 00872320002503 | 002-00280 | 002-00280 | Charging cradle/stand for use with the Pioneer Elite Diode Laser. | GEX | Powered Laser Surgical Instrument | Pioneer Elite Charging Cradle | |
| 14 | 00872320002473 | 002-00277 | 002-00277 | Therapeutic treatment handpiece for use with the Pioneer Elite Diode Laser. | GEX | Powered Laser Surgical Instrument | Pioneer Elite Therapy Handpiece | |
| 15 | 00872320001742 | 002-00226 | 002-00226 | Removeable handpiece sleeve for use with the Precise SHP Diode Laser. | GEX | Powered Laser Surgical Instrument | 2 | Precise SHP Handpiece Sleeve |
| 16 | 00872320005498 | 005-00050 | Replacement inlet collector for the Aegis Aerosol VacStation. | EHZ | Evacuator, Oral Cavity | 1 | Aegis Aerosol VacStation Primary Filter | |
| 17 | 00872320005481 | 005-00049 | Replacement collection tube for the Aegis Aerosol VacStation. | EHZ | Evacuator, Oral Cavity | 1 | Aegis Aerosol VacStation Primary Filter | |
| 18 | 00872320005474 | 005-00048 | Replacement charcoal filter cartridge for the Aegis Aerosol VacStation. | EHZ | Evacuator, Oral Cavity | 1 | Aegis Aerosol VacStation Primary Filter | |
| 19 | 00872320005467 | 005-00047 | Replacement secondary fiberglass filter for the Aegis Aerosol VacStation. | EHZ | Evacuator, Oral Cavity | 1 | Aegis Aerosol VacStation Primary Filter | |
| 20 | 00872320005443 | 005-00080 | Reusable non-woven poly protective suit. Extra, extra, extra, extra, extra large size. | OEA | Non-Surgical Isolation Gown | 1 | Aegis Personal Protective Suit | |
| 21 | 00872320005436 | 005-00079 | Reusable non-woven poly protective suit. Extra, extra, extra, extra large size. | OEA | Non-Surgical Isolation Gown | 1 | Aegis Personal Protective Suit | |
| 22 | 00872320005429 | 005-00078 | Reusable non-woven poly protective suit. Extra, extra, extra large size. | OEA | Non-Surgical Isolation Gown | 1 | Aegis Personal Protective Suit | |
| 23 | 00872320005412 | 005-00077 | Reusable non-woven poly protective suit. Extra, extra large size. | OEA | Non-Surgical Isolation Gown | 1 | Aegis Personal Protective Suit | |
| 24 | 00872320005399 | 005-00075 | Reusable non-woven poly protective suit. Large size. | OEA | Non-Surgical Isolation Gown | 1 | Aegis Personal Protective Suit | |
| 25 | 00872320005382 | 005-00074 | Reusable non-woven poly protective suit. Medium size. | OEA | Non-Surgical Isolation Gown | 1 | Aegis Personal Protective Suit | |
| 26 | 00872320005375 | 005-00073 | Reusable non-woven poly protective suit. Small size. | OEA | Non-Surgical Isolation Gown | 1 | Aegis Personal Protective Suit | |
| 27 | 00872320005368 | 005-00072 | Reusable non-woven poly protective suit. Extra small size. | OEA | Non-Surgical Isolation Gown | 1 | Aegis Personal Protective Suit | |
| 28 | 00872320005344 | 005-00071 | Single use 2-piece protective suit. Extra, extra, extra, extra, extra large size. | OEA | Non-Surgical Isolation Gown | 1 | Aegis Personal Protective Suit | |
| 29 | 00872320005320 | 005-00070 | Single use 2-piece protective suit. Extra, extra, extra, extra large size. | OEA | Non-Surgical Isolation Gown | 1 | Aegis Personal Protective Suit | |
| 30 | 00872320005603 | 005-00086 | Replacement small square inlet collector for the Aegis Aerosol VacStation. | EHZ | Evacuator, Oral Cavity | 1 | Aegis Aerosol VacStation Small Inlet Collector | |
| 31 | 00872320005535 | 005-00083 | Reusable non-woven poly protective suit. Extra, extra, extra, extra, extra, extr Reusable non-woven poly protective suit. Extra, extra, extra, extra, extra, extra large size. | OEA | Non-Surgical Isolation Gown | 1 | Aegis Personal Protective Suit | |
| 32 | 00872320005528 | 005-00082 | Single use 2-piece protective suit. Extra, extra, extra, extra, extra, extra large size. | OEA | Non-Surgical Isolation Gown | 1 | Aegis Personal Protective Suit | |
| 33 | 00872320005511 | 005-00081 | Reusable polyester protective suit. Extra, extra, extra, extra, extra, extra large size. | OEA | Non-Surgical Isolation Gown | 1 | Aegis Personal Protective Suit | |
| 34 | 00872320005405 | 005-00076 | Reusable non-woven poly protective suit. Extra large size. | OEA | Non-Surgical Isolation Gown | 1 | Aegis Personal Protective Suit | |
| 35 | 00872320005504 | 005-00046 | Replacement primary cotton filter for the Aegis Aerosol VacStation. | EHZ | Evacuator, Oral Cavity | 1 | Aegis Aerosol VacStation Primary Filter | |
| 36 | 00872320005306 | 005-00069 | Reusable polyester protective suit. Extra, extra, extra, extra, extra large size. | OEA | Non-Surgical Isolation Gown | 1 | Aegis Personal Protective Suit | |
| 37 | 00872320005283 | 005-00068 | Reusable polyester protective suit. Extra, extra, extra, extra large size. | OEA | Non-Surgical Isolation Gown | 1 | Aegis Personal Protective Suit | |
| 38 | 00872320005276 | 005-00064 | Single use 2-piece protective suit. Extra, extra, extra large size. | OEA | Non-Surgical Isolation Gown | 1 | Aegis Personal Protective Suit | |
| 39 | 00872320005269 | 005-00063 | Single use 2-piece protective suit. Extra, extra large size. | OEA | Non-Surgical Isolation Gown | 1 | Aegis Personal Protective Suit | |
| 40 | 00872320005252 | 005-00062 | Single use 2-piece protective suit. Extra large size. | OEA | Non-Surgical Isolation Gown | 1 | Aegis Personal Protective Suit | |
| 41 | 00872320005245 | 005-00061 | Single use 2-piece protective suit. Large size. | OEA | Non-Surgical Isolation Gown | 1 | Aegis Personal Protective Suit | |
| 42 | 00872320005238 | 005-00060 | Single use 2-piece protective suit. Medium size. | OEA | Non-Surgical Isolation Gown | 1 | Aegis Personal Protective Suit | |
| 43 | 00872320005221 | 005-00059 | Single use 2-piece protective suit. Small size. | OEA | Non-Surgical Isolation Gown | 1 | Aegis Personal Protective Suit | |
| 44 | 00872320005214 | 005-00058 | Single use 2-piece protective suit. Extra small size. | OEA | Non-Surgical Isolation Gown | 1 | Aegis Personal Protective Suit | |
| 45 | 00872320005207 | 005-00057 | Reusable polyester protective suit. Extra, extra, extra large size. | OEA | Non-Surgical Isolation Gown | 1 | Aegis Personal Protective Suit | |
| 46 | 00872320005191 | 005-00056 | Reusable polyester protective suit. Extra, extra large size. | OEA | Non-Surgical Isolation Gown | 1 | Aegis Personal Protective Suit | |
| 47 | 00872320005184 | 005-00055 | Reusable polyester protective suit. Extra large size. | OEA | Non-Surgical Isolation Gown | 1 | Aegis Personal Protective Suit | |
| 48 | 00872320005177 | 005-00054 | Reusable polyester protective suit. Large size. | OEA | Non-Surgical Isolation Gown | 1 | Aegis Personal Protective Suit | |
| 49 | 00872320005160 | 005-00053 | Reusable polyester protective suit. Medium size. | OEA | Non-Surgical Isolation Gown | 1 | Aegis Personal Protective Suit | |
| 50 | 00872320005153 | 005-00052 | Reusable polyester protective suit. Small size. | OEA | Non-Surgical Isolation Gown | 1 | Aegis Personal Protective Suit |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 03830054230996 | M002-6A/2 PRO | The Fotona LightWalker laser system range incorporates treatment lasers that ope The Fotona LightWalker laser system range incorporates treatment lasers that operate in the invisible near-infrared (Nd:YAG 1064 nm) and mid-infrared (Er:YAG 2940 nm) ranges of the electromagnetic spectrum, along with an aiming beam laser that operates in the visible range. The incorporated lasers and their handpieces were developed for therapeutic use in dentistry for soft- and hard-tissue treatments, and for use in aesthetic and dermatological procedures. The Er:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery.The Nd:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery. | LightWalker ST-E PRO | FOTONA D.O.O. | |
| 2 | 03830054230897 | M002-6A/2 ADVANCED | The Fotona LightWalker laser system range incorporates treatment lasers that ope The Fotona LightWalker laser system range incorporates treatment lasers that operate in the invisible near-infrared (Nd:YAG 1064 nm) and mid-infrared (Er:YAG 2940 nm) ranges of the electromagnetic spectrum, along with an aiming beam laser that operates in the visible range. The incorporated lasers and their handpieces were developed for therapeutic use in dentistry for soft- and hard-tissue treatments, and for use in aesthetic and dermatological procedures. The Er:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery.The Nd:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery. | Lightwalker ST-E ADVANCED | FOTONA D.O.O. | |
| 3 | 03830054230798 | M021-5AF/2 ADVANCED | The Fotona LightWalker laser system range incorporates treatment lasers that ope The Fotona LightWalker laser system range incorporates treatment lasers that operate in the invisible near-infrared (Nd:YAG 1064 nm) and mid-infrared (Er:YAG 2940 nm) ranges of the electromagnetic spectrum, along with an aiming beam laser that operates in the visible range. The incorporated lasers and their handpieces were developed for therapeutic use in dentistry for soft- and hard-tissue treatments, and for use in aesthetic and dermatological procedures. The Er:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery.The Nd:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery. | Lightwalker DT ADVANCED | FOTONA D.O.O. | |
| 4 | 03830054230699 | M021-5AF/1 S | The Fotona LightWalker laser system range incorporates treatment lasers that ope The Fotona LightWalker laser system range incorporates treatment lasers that operate in the invisible near-infrared (Nd:YAG 1064 nm) and mid-infrared (Er:YAG 2940 nm) ranges of the electromagnetic spectrum, along with an aiming beam laser that operates in the visible range. The incorporated lasers and their handpieces were developed for therapeutic use in dentistry for soft- and hard-tissue treatments, and for use in aesthetic anddermatological procedures. The Er:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery.The Nd:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery. | Lightwalker AT S | FOTONA D.O.O. | |
| 5 | 03830054230590 | M002-6A/2 STAND | The Fotona LightWalker laser system range incorporates treatment lasers that ope The Fotona LightWalker laser system range incorporates treatment lasers that operate in the invisible near-infrared (Nd:YAG 1064 nm) and mid-infrared (Er:YAG 2940 nm) ranges of the electromagnetic spectrum, along with an aiming beam laser that operates in the visible range. The incorporated lasers and their handpieces were developed for therapeutic use in dentistry for soft- and hard-tissue treatments, and for use in aesthetic and dermatological procedures. The Er:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery.The Nd:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery. | Lightwalker ST-E STAND | FOTONA D.O.O. | |
| 6 | 03830054230514 | M002-6A/2 | The device and its accessories are intended to be used in the fields of dentistr The device and its accessories are intended to be used in the fields of dentistry, aesthetics, dermatology, gynecology and urology, ENT, surgery and pain management. | TimeWalker ST-E | FOTONA D.O.O. | |
| 7 | 03830054230507 | M021-5AF/1 | The device and its accessories are intended to be used in the fields of dentistr The device and its accessories are intended to be used in the fields of dentistry, aesthetics, dermatology, gynecology and urology, ENT, surgery and pain management. | TimeWalker AT | FOTONA D.O.O. | |
| 8 | 03830054230491 | M021-5AF/2 STAND | The Fotona LightWalker laser system range incorporates treatment lasers that ope The Fotona LightWalker laser system range incorporates treatment lasers that operate in the invisible near-infrared (Nd:YAG 1064 nm) and mid-infrared (Er:YAG 2940 nm) ranges of the electromagnetic spectrum, along with an aiming beam laser that opehttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageDataLoaded=false&pageMode=create#rates in the visible range. The incorporated lasers and their handpieces were developed for therapeutic use in dentistry for soft- and hard-tissue treatments, and for use in aesthetic and dermatological procedures. The Er:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery.The Nd:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery | Lightwalker DT STAND | FOTONA D.O.O. | |
| 9 | 03830054230484 | M031-3A/2 PQX | The Fotona StarWalker PQX laser system and its accessories are intended for tatt The Fotona StarWalker PQX laser system and its accessories are intended for tattoo removal, treatment of pigmented lesions and aesthetic applications requiring selective photothermolysis of target chromophores in soft tissue, and ablation and vaporization of soft tissue in general dermatology. | StarWalker | FOTONA D.O.O. | |
| 10 | 03830054230408 | M321-B | The Fotona SkyPulse Laser Platform consists of a console, a footswitch and attac The Fotona SkyPulse Laser Platform consists of a console, a footswitch and attachable laser modules. The Fotona SkyPulse Laser Platform is a multi-application, multi-technology platform that supports the following modules: i) Flash-lamp pumped solid state laser modules and ii) Diode laser modules. Output parameters and other system features are controlled from the touch-screen control panel on the console, which provides an interface to the system microcontroller through an LCD touch-screen. | SkyPulse | FOTONA D.O.O. | |
| 11 | 03830054230392 | M321-A | The Fotona SkyPulse Laser Platform consists of a console, a footswitch and attac The Fotona SkyPulse Laser Platform consists of a console, a footswitch and attachable laser modules. The Fotona SkyPulse Laser Platform is a multi-application, multi-technology platform that supports the following modules: i) Flash-lamp pumped solid state laser modules and ii) Diode laser modules. Output parameters and other system features are controlled from the touch-screen control panel on the console, which provides an interface to the system microcontroller through an LCD touch-screen. | SkyPulse | FOTONA D.O.O. | |
| 12 | 03830054230354 | M031-3A/2 QX | The StarWalker Fotona QX MAX (QX and MaQX) laser system and its accessories are The StarWalker Fotona QX MAX (QX and MaQX) laser system and its accessories are intended for tattoo removal, treatment of pigmented and vascular lesions, surgical and aesthetic applications requiring selective photothermolysis of target chromophores in soft tissue, and incision/excision, ablation and vaporization ofsoft tissue in general dermatology. | StarWalker | FOTONA D.O.O. | |
| 13 | 03830054230347 | M002-6A/2 ADVANCED | The Fotona LightWalker laser system range incorporates treatment lasers that ope The Fotona LightWalker laser system range incorporates treatment lasers that operate in the invisible near-infrared (Nd:YAG 1064 nm) and mid-infrared (Er:YAG 2940 nm) ranges of the electromagnetic spectrum, along with an aiming beam laser that operates in the visible range. The incorporated lasers and their handpieces were developed for therapeutic use in dentistry for soft- and hard-tissue treatments, and for use in aesthetic and dermatological procedures. The Er:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery.The Nd:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery. | LightWalker ST-E ADVANCED | FOTONA D.O.O. | |
| 14 | 03830054230330 | M031-3A/2 MAQX | The StarWalker Fotona QX MAX (QX and MaQX) laser system and its accessories are The StarWalker Fotona QX MAX (QX and MaQX) laser system and its accessories are intended for tattoo removal, treatment of pigmented and vascular lesions, surgical and aesthetic applications requiring selective photothermolysis of target chromophores in soft tissue, and incision/excision, ablation and vaporization ofsoft tissue in general dermatology. | StarWalker | FOTONA D.O.O. | |
| 15 | 03830054230293 | M002-6A/2 | The Fotona LightWalker laser system range incorporates treatment lasers that ope The Fotona LightWalker laser system range incorporates treatment lasers that operate in the invisible near-infrared (Nd:YAG 1064 nm) and mid-infrared (Er:YAG 2940 nm) ranges of the electromagnetic spectrum, along with an aiming beam laser that operates in the visible range. The incorporated lasers and their handpieces were developed for therapeutic use in dentistry for soft- and hard-tissue treatments, and for use in aesthetic and dermatological procedures. The Er:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery.The Nd:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery. | Lightwalker ST-E | FOTONA D.O.O. | |
| 16 | 03830054230231 | M001-14F 2 | "The Fotona XP Focus family of laser systems consists of the XP-2 Focus and the "The Fotona XP Focus family of laser systems consists of the XP-2 Focus and the XP Focus, which is available in a table-top version or mobile version with an undercarriage that provides additional storage space. All laser systems within the family incorporate a treatment laser that operates in the invisible, near-infrared range of the electromagnetic spectrum and an aiming laser that operates in the visible range.XP Focus family laser systems incorporate:· A Nd:YAG laser source operating at a wavelength of 1064 nm in PULSE and Quasi Continuous Wave (QCW) mode of operation.· An aiming semiconductor diode laser operating at a wavelength of 650 nm.The Variable Square Pulse (VSP) Technology incorporated in the laser systems provides control of laser energy and laser pulse length." | Fotona XP-2 Focus | FOTONA D.O.O. | |
| 17 | 03830054230224 | M001-14F 1 | The Fotona XP Focus family of laser systems consists of the XP-2 Focus and the X The Fotona XP Focus family of laser systems consists of the XP-2 Focus and the XP Focus, which is available in a table-top version or mobile version with anundercarriage that provides additional storage space. All laser systems within the family incorporate a treatment laser that operates in the invisible, near-infrared range of the electromagnetic spectrum and an aiming laser that operates in the visible range.XP Focus family laser systems incorporate:· A Nd:YAG laser source operating at a wavelength of 1064 nm in PULSE and Quasi Continuous Wave (QCW) mode of operation.· An aiming semiconductor diode laser operating at a wavelength of 650 nm.The Variable Square Pulse (VSP) Technology incorporated in the laser systems provides control of laser energy and laser pulse length. | Fotona XP Focus | FOTONA D.O.O. | |
| 18 | 03830054230217 | M001-12F | The Fotona Dynamis Pro Line of laser systems incorporate lasers that operate in The Fotona Dynamis Pro Line of laser systems incorporate lasers that operate in the invisible near- and mid-infrared ranges of the electromagnetic spectrum, aswell as an aiming beam laser that operates in the visible range.The Variable Square Pulse (VSP) Technology integrated in Fotona’s laser systems allows control of laser energy and laser pulse length. The Dynamis laser system family is intended to be used in the field of dermatology, aesthetic medicine, gynecology, genitourology and surgery. | XP Spectro | FOTONA D.O.O. | |
| 19 | 03830054230200 | M021-4AF/3 | "The Fotona Dynamis Pro Line of laser systems incorporate lasers that operate in "The Fotona Dynamis Pro Line of laser systems incorporate lasers that operate in the invisible near- and mid-infrared ranges of the electromagnetic spectrum, as well as an aiming beam laser that operates in the visible range.The Variable Square Pulse (VSP) Technology integrated in Fotona’s laser systems allows control of laser energy and laser pulse length. The Dynamis laser system family is intended to be used in the field of dermatology, aesthetic medicine, gynecology, genitourology and surgery." | SP Spectro | FOTONA D.O.O. | |
| 20 | 03830054230194 | M021-5AF/1 | The Fotona LightWalker laser system range incorporates treatment lasers that ope The Fotona LightWalker laser system range incorporates treatment lasers that operate in the invisible near-infrared (Nd:YAG 1064 nm) and mid-infrared (Er:YAG 2940 nm) ranges of the electromagnetic spectrum, along with an aiming beam laser that operates in the visible range.The incorporated lasers and their handpieces were developed for therapeutic use in dentistry for soft- and hard-tissue treatments, and for use in aesthetic anddermatological procedures. The Er:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery.The Nd:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery. | Lightwalker AT | FOTONA D.O.O. | |
| 21 | 03830054230170 | M001-14F | The Fotona XP Focus family of laser systems consists of the XP-2 Focus and the X The Fotona XP Focus family of laser systems consists of the XP-2 Focus and the XP Focus, which is available in a table-top version or mobile version with anundercarriage that provides additional storage space. All laser systems within the family incorporate a treatment laser that operates in the invisible, near-infrared range of the electromagnetic spectrum and an aiming laser that operates in the visible range.XP Focus family laser systems incorporate:· A Nd:YAG laser source operating at a wavelength of 1064 nm in PULSE and Quasi Continuous Wave (QCW) mode of operation.· An aiming semiconductor diode laser operating at a wavelength of 650 nm.The Variable Square Pulse (VSP) Technology incorporated in the laser systems provides control of laser energy and laser pulse length. | Fotona XP Focus | FOTONA D.O.O. | |
| 22 | 03830054230163 | M001-12F | The Fotona XP Max (DualisXP Plus II) laser system incorporates a treatment laser The Fotona XP Max (DualisXP Plus II) laser system incorporates a treatment laser that operates in the invisible near-infrared range of the electromagnetic spectrum, and an aiming beam laser that operates in the visible range.The Variable Square Pulse (VSP) Technology implemented in the laser systems allows ultimate control of laser energy and laser pulse length.The Fotona XP Max (DualisXP Plus II) laser system incorporates the following laser sources:· A long-pulse Nd:YAG laser, with a wavelength of 1064 nm· An aiming beam diode laser, with a wavelength of 650 nmThe Fotona XP MAX (DualisXP Plus II) Nd:YAG laser system and its accessories is indicated for use in surgical and aesthetic applications requiring the selective photothermolysis of target chromophores in soft tissue in the medical specialties of general and plastic surgery and dermatology. | Fotona XP Max | FOTONA D.O.O. | |
| 23 | 03830054230125 | M002-2A | The Fotona Dynamis Pro Line of laser systems incorporate lasers that operate in The Fotona Dynamis Pro Line of laser systems incorporate lasers that operate in the invisible near- and mid-infrared ranges of the electromagnetic spectrum, aswell as an aiming beam laser that operates in the visible range.The Variable Square Pulse (VSP) Technology integrated in Fotona’s laser systems allows control of laser energy and laser pulse length. The Dynamis laser system family is intended to be used in the field of dermatology, aesthetic medicine, gynecology, genitourology and surgery. | XS Dynamis | FOTONA D.O.O. | |
| 24 | 03830054230118 | M001-12F | The Fotona Dynamis Pro Line of laser systems incorporate lasers that operate in The Fotona Dynamis Pro Line of laser systems incorporate lasers that operate in the invisible near- and mid-infrared ranges of the electromagnetic spectrum, aswell as an aiming beam laser that operates in the visible range.The Variable Square Pulse (VSP) Technology integrated in Fotona’s laser systems allows control of laser energy and laser pulse length. The Dynamis laser system family is intended to be used in the field of dermatology, aesthetic medicine, gynecology, genitourology and surgery | XP Dynamis | FOTONA D.O.O. | |
| 25 | 03830054230101 | M021-4AF/3 | The Fotona Dynamis Pro Line of laser systems incorporate lasers that operate in The Fotona Dynamis Pro Line of laser systems incorporate lasers that operate in the invisible near- and mid-infrared ranges of the electromagnetic spectrum, aswell as an aiming beam laser that operates in the visible range.The Variable Square Pulse (VSP) Technology integrated in Fotona’s laser systems allows control of laser energy and laser pulse length. The Dynamis laser system family is intended to be used in the field of dermatology, aesthetic medicine, gynecology, genitourology and surgery. | SP Dynamis | FOTONA D.O.O. | |
| 26 | 03830054230095 | M021-5AF/2 | "The Fotona LightWalker laser system range incorporates treatment lasers that op "The Fotona LightWalker laser system range incorporates treatment lasers that operate in the invisible near-infrared (Nd:YAG 1064 nm) and mid-infrared (Er:YAG 2940 nm) ranges of the electromagnetic spectrum, along with an aiming beam laser that operates in the visible range. The incorporated lasers and their handpieces were developed for therapeutic use in dentistry for soft- and hard-tissue treatments, and for use in aesthetic and dermatological procedures. The Er:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery.The Nd:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery. " | Lightwalker DT | FOTONA D.O.O. | |
| 27 | 03830054230064 | M031-3A/2 | The Fotona QX laser system family incorporates a treatment laser that operates i The Fotona QX laser system family incorporates a treatment laser that operates in the invisible mid-infrared and visible range of the electromagnetic spectrum.Variable Square Pulse (VSP) Technology implemented in the laser systems allows ultimate control of laser energy and laser pulse length.The Fotona QX MAX laser system and its accessories are intended for tattoo removal, treatment of pigmented and vascular lesions, surgical and aestheticapplications requiring selective photothermolysis of target chromophores in soft tissue, and incision/excision, ablation and vaporization of soft tissue in generaldermatology. | Fotona QX Max | FOTONA D.O.O. | |
| 28 | 03760227850198 | SK+-EO-980-25-600-3 | STERILE MEDICAL HANDPIECE FOR SINGLE USE | SMOOTHKIT+ | LSO MEDICAL | |
| 29 | 03760227850174 | OSYHAND | STERILE MEDICAL HANDPIECE FOR SINGLE USE | OSYHAND | LSO MEDICAL | |
| 30 | 03760227850150 | PH-EO-980-25-600-3 | STERILE MEDICAL OPTICAL FIBER FOR SINGLE USE | OSYFIBRE | LSO MEDICAL | |
| 31 | 03700542625569 | VITRA 2 | The VITRA 2 is a laser system which emits a treatment beam at 532 nm and is inte The VITRA 2 is a laser system which emits a treatment beam at 532 nm and is intended for use in photocoagulation of ocular tissues in the treatment of diseases of the eye. | VITRA 2 | QUANTEL MEDICAL | |
| 32 | 03700542625415 | VMS | 532nm Multispot LaserRetinal Photocoagulation | VITRA MULTISPOT | QUANTEL MEDICAL | |
| 33 | 03700542625309 | SUPSC532OPT | SUPRASCAN 532nm adaptor for OPTIMIS II (MultiSpot) | SUPRASCAN 532nm for OPTIMIS II | QUANTEL MEDICAL | |
| 34 | 03700542625293 | SUPSC532 | 532nm adaptor for HS900 BM/BQ Slit Lamp (MultiSpot) | SUPRASCAN 532nm | QUANTEL MEDICAL | |
| 35 | 03662824000207 | D029AF001C08A | E>EYE C | E-SWIN | ||
| 36 | 011000009 | AL 10000 V400 7 Series | XTRAC | STRATA SKIN SCIENCES, INC. | ||
| 37 | 011000008 | AL 10000 V400 XL 7 series | XTRAC | STRATA SKIN SCIENCES, INC. | ||
| 38 | 011000007 | AL 10000 V7 7 Series | XTRAC | STRATA SKIN SCIENCES, INC. | ||
| 39 | 011000006 | AL 10000 V700 XL | XTRAC | STRATA SKIN SCIENCES, INC. | ||
| 40 | 011000005 | AL 10000 V700 | XTRAC | STRATA SKIN SCIENCES, INC. | ||
| 41 | 011000004 | AL 10000 V400XL | XTRAC | STRATA SKIN SCIENCES, INC. | ||
| 42 | 011000002 | AL10000 V400 | XTRAC | STRATA SKIN SCIENCES, INC. | ||
| 43 | 010822603 | AL 8000 Ultra Plus 7 Series | XTRAC | STRATA SKIN SCIENCES, INC. | ||
| 44 | 010822602 | AL 8000 Ultra Plus | XTRAC | STRATA SKIN SCIENCES, INC. | ||
| 45 | 010800004 | AL 8000 | XTRAC | STRATA SKIN SCIENCES, INC. | ||
| 46 | 010800003 | AL 8000 | XTRAC | STRATA SKIN SCIENCES, INC. | ||
| 47 | 010800002 | AL 8000 | XTRAC | STRATA SKIN SCIENCES, INC. | ||
| 48 | 010800001 | AL 8000 | XTRAC | STRATA SKIN SCIENCES, INC. | ||
| 49 | 00894338002962 | OTO-HP-4 | OTO-HP-4 | Handpiece | BeamPath OTO Handpiece, 4cm working length | OMNIGUIDE, INC. |
| 50 | 00894338002955 | 321019 | 321019 | Elevate™ENT Handpiece | Elevate™ENT Handpiece 14cm 21° -S | OMNIGUIDE, INC. |