| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 06974214160192 | CHERYLAS-20N | Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, a Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, and exempt from 510(K) | ILY | Lamp, Infrared, Therapeutic Heating | 2 | Dimed | |
| 2 | 06974214160185 | CHERYLAS-15N | Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, a Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, and exempt from 510(K) | ILY | Lamp, Infrared, Therapeutic Heating | 2 | Dimed | |
| 3 | 06974214160178 | CHERYLAS-60K | Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, a Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, and exempt from 510(K) | ILY | Lamp, Infrared, Therapeutic Heating | 2 | Dimed | |
| 4 | 06974214160161 | CHERYLAS-70J | Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, a Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, and exempt from 510(K) | ILY | Lamp, Infrared, Therapeutic Heating | 2 | Dimed | |
| 5 | 06974214160154 | CHERYLAS-60J | Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, a Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, and exempt from 510(K) | ILY | Lamp, Infrared, Therapeutic Heating | 2 | Dimed | |
| 6 | 06974214160147 | CHERYLAS-30J | Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, a Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, and exempt from 510(K) | ILY | Lamp, Infrared, Therapeutic Heating | 2 | Dimed | |
| 7 | 06974214160130 | CHERYLAS-70I | Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, a Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, and exempt from 510(K) | ILY | Lamp, Infrared, Therapeutic Heating | 2 | Dimed | |
| 8 | 06974214160123 | CHERYLAS-60I | Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, a Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, and exempt from 510(K) | ILY | Lamp, Infrared, Therapeutic Heating | 2 | Dimed | |
| 9 | 06974214160116 | CHERYLAS-30I | Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, a Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, and exempt from 510(K) | ILY | Lamp, Infrared, Therapeutic Heating | 2 | Dimed | |
| 10 | 06974214160093 | BERYLAS-10I | Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, a Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, and exempt from 510(K) | ILY | Lamp, Infrared, Therapeutic Heating | 2 | Dimed | |
| 11 | 06974214160086 | BERYLAS-10J | Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, a Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, and exempt from 510(K) | ILY | Lamp, Infrared, Therapeutic Heating | 2 | Dimed | |
| 12 | 06974214160079 | BERYLAS-10F | Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, a Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, and exempt from 510(K) | ILY | Lamp, Infrared, Therapeutic Heating | 2 | Dimed | |
| 13 | 06974214160062 | BERYLAS-10FI | Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, a Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, and exempt from 510(K) | ILY | Lamp, Infrared, Therapeutic Heating | 2 | Dimed | |
| 14 | 06974214160055 | BERYLAS-10FJ | Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, a Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, and exempt from 510(K) | ILY | Lamp, Infrared, Therapeutic Heating | 2 | Dimed | |
| 15 | 06974214160048 | BERYLAS-15I | Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, a Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, and exempt from 510(K) | ILY | Lamp, Infrared, Therapeutic Heating | 2 | Dimed | |
| 16 | 06974214160031 | BERYLAS-15J | Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, a Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, and exempt from 510(K) | ILY | Lamp, Infrared, Therapeutic Heating | 2 | Dimed | |
| 17 | 06974214160024 | BERYLAS-15F | Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, a Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, and exempt from 510(K) | ILY | Lamp, Infrared, Therapeutic Heating | 2 | Dimed | |
| 18 | 06974214160017 | BERYLAS-15FI | Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, a Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, and exempt from 510(K) | ILY | Lamp, Infrared, Therapeutic Heating | 2 | Dimed | |
| 19 | 06974214160000 | BERYLAS-15FJ | Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, a Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, and exempt from 510(K) | ILY | Lamp, Infrared, Therapeutic Heating | 2 | Dimed |
| 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 | 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. | |
| 7 | 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. | |
| 8 | 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. | |
| 9 | 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. | |
| 10 | 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. | |
| 11 | 03760262493107 | PREMIO 10 | 111237 | The PREMIO 10 – Moxa is a medical device for heat therapy. It consists of the fo The PREMIO 10 – Moxa is a medical device for heat therapy. It consists of the following:• A handpiece with a Power Supply (110-240V~ /50-60Hz)• A tip concentrator• An user manual• A cover of arrangementThe PREMIO 10 - MOXA is a non-invasive infrared lamp intended to provide topical heating. The PREMIO 10 - MOXA is indicated for temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated. | PREMIO 10 MOXA | SEDATELEC |
| 12 | 00888912368964 | 70008 | NEO PATIENT REMOTE | CHATTANOOGA | DJO, LLC | |
| 13 | 00888912368933 | 70005 | NEO MODULE LASER | CHATTANOOGA | DJO, LLC | |
| 14 | 00888912294393 | 27904K | KIT INTERLOCK LASERMOBILE/TRAN | CHATTANOOGA | DJO, LLC | |
| 15 | 00888912294386 | 27900K-SP | SERVICE PART KIT INTERLOCK EPR LASER MODULE | CHATTANOOGA | DJO, LLC | |
| 16 | 00888912294379 | 27900K | KIT INTERLOCK EPR LASER DOOR MODULE | CHATTANOOGA | DJO, LLC | |
| 17 | 00888912294003 | 27841 | APPLICATOR SINGLE 850NM 200MW | CHATTANOOGA | DJO, LLC | |
| 18 | 00888912293990 | 27840 | APPLICATOR SINGLE 850NM 100MW | CHATTANOOGA | DJO, LLC | |
| 19 | 00888912293983 | 2784 | VECTRA GENISYS LASER PKG | CHATTANOOGA | DJO, LLC | |
| 20 | 00888912293891 | 27816 | APPLICATOR 13CLS 3X200MW 715MW | CHATTANOOGA | DJO, LLC | |
| 21 | 00888912293884 | 27815 | APPLICATOR 19CLS LED 325MW | CHATTANOOGA | DJO, LLC | |
| 22 | 00888912293877 | 27814 | APPLICATOR 13CLSX100MW 415MW | CHATTANOOGA | DJO, LLC | |
| 23 | 00888912293860 | 27813 | APPLICATOR 13CLS 3X50MW 265MW | CHATTANOOGA | DJO, LLC | |
| 24 | 00888912293853 | 27812 | APPLICATOR 9CLS 5X200MW 1040MW | CHATTANOOGA | DJO, LLC | |
| 25 | 00888912293846 | 27811 | APPLICATOR 9CLS 5X100MW 540MW | CHATTANOOGA | DJO, LLC | |
| 26 | 00888912293839 | 27810 | APPLICATOR 9CLS 5X50MW 290MW | CHATTANOOGA | DJO, LLC | |
| 27 | 00888912293808 | 27809 | APPLICATOR 33CLS LED 565MW | CHATTANOOGA | DJO, LLC | |
| 28 | 00888912293792 | 27808 | APPLICATOR 33CLS 5X200MW 1440MW | CHATTANOOGA | DJO, LLC | |
| 29 | 00888912293785 | 27807 | APPLICATOR 33CLS 5X100MW 940MW | CHATTANOOGA | DJO, LLC | |
| 30 | 00888912293778 | 27805 | APPLICATOR SINGLE 820NM 300MW | CHATTANOOGA | DJO, LLC | |
| 31 | 00888912293761 | 27804 | APPLICATOR 850NM 150MW LASER | CHATTANOOGA | DJO, LLC | |
| 32 | 00888912293754 | 27803 | APPLICATOR SINGLE 850NM 40MW | CHATTANOOGA | DJO, LLC | |
| 33 | 00888912293747 | 27802 | APPLICATOR 33CLS 5X50MW 690MW | CHATTANOOGA | DJO, LLC | |
| 34 | 00888912293693 | 27799 | APPLICATOR SINGLE 670NM 10MW | CHATTANOOGA | DJO, LLC | |
| 35 | 00888912292672 | 2758 | LASER MODULE VECTRA/GEN PKG | CHATTANOOGA | DJO, LLC | |
| 36 | 00888912236010 | 13651 | SWIT PATIENT LASER STOP | CHATTANOOGA | DJO, LLC | |
| 37 | 00866085000409 | IR-20 | IR-20 | IVIMEA | ||
| 38 | 00865198000320 | Model 1600 | Infrared Heating Device | Pain-x-2000 | DIOMEDICS LIGHT THERAPY INC | |
| 39 | 00865198000313 | Infrabed | Infrared Heating Device | Pain-x-2000 | DIOMEDICS LIGHT THERAPY INC | |
| 40 | 00865198000306 | Therapy Boot system | Infrared Heating Device | Pain-x-2000 | DIOMEDICS LIGHT THERAPY INC | |
| 41 | 00862662000213 | DLW2X4 | Lumiwave Double, 400 LED's, 2x4 Pods | LUMIWAVE | BIOCARE SYSTEMS INC | |
| 42 | 00862662000206 | SLW1X4 | Lumiwave Single LED, 200 LED's, 1x4 Pods | LUMIWAVE | BIOCARE SYSTEMS INC | |
| 43 | 00861407000389 | 8990 | Gemini 810+980 Diode Laser Kit, International | AZENA MEDICAL, LLC | ||
| 44 | 00860925000338 | 60008 | 60008 | UltraSlim Digital, Red Light (635nm) | UltraSlim Digital | WARD PHOTONICS LLC |
| 45 | 00860003478103 | Painbuster | Red/Infrared LED & Laser Therapy Device for Pain Relief. | PainBuster | MIESSENTIA MEDICAL USA LLC | |
| 46 | 00860001452549 | Electro Light Therapy | Electro Light Therapy | HILL LABORATORIES CO. | ||
| 47 | 00860000214056 | 55105 | SynRG Light Pad | RST- SANEXAS | ||
| 48 | 00860000214025 | 55105 | SynRG Light Pad | RST- SANEXAS | ||
| 49 | 00859626006343 | ML-830-07-100 | ML-830-07-100 | Smart Laser DP | ML 830® | MICROLIGHT CORPORATION OF AMERICA |
| 50 | 00859626006275 | ML-830-07-002 | ML-830-07-002 | SL Single Probe | ML 830® | MICROLIGHT CORPORATION OF AMERICA |