| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 08800020101013 | INTRAcel | Fractional RF Microneedle System | GEI | Electrosurgical, Cutting & Coagulation & Accessories | INTRAcel | ||
| 2 | 08800020100214 | Demokit | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | POTENZA Demokit | ||
| 3 | 08800020104021 | Edge Arm | Articulated arm | ONG | Powered Laser Surgical Instrument With Microbeam\Fractional Output | 2 | Edge Arm | |
| 4 | 08800020100948 | D'Liv Handpiece | GEY | Motor, Surgical Instrument, Ac-Powered | 1 | D'Liv Handpiece | ||
| 5 | 08800020100931 | D'Liv Main Body | GEY | Motor, Surgical Instrument, Ac-Powered | 1 | D'Liv Main Body | ||
| 6 | 08800020110015 | Edge ONE | CO2 Fractional laser system | ONG,GEX | Powered Laser Surgical Instrument With Microbeam\Fractional Output,Powered Laser Powered Laser Surgical Instrument With Microbeam\Fractional Output,Powered Laser Surgical Instrument | 2 | Edge ONE | |
| 7 | 08800020102010 | TRI-BEAM | POWERED LASER SURGICAL INSTRUMENT | GEX | Powered Laser Surgical Instrument | Tri-Beam Nd:YAG Laser System | ||
| 8 | 08800020101020 | 1011 | Sterile micro needle electrode | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | INTRAcel Tip | |
| 9 | 08800020111012 | POTENZA | Fractional RF Microneedle System | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | POTENZA | |
| 10 | 08800020100009 | LIPOcel | Focused Ultrasound for tissue heat or mechanical cellular disruption | OHV | Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption | 2 | LIPOcel | |
| 11 | 08800020105042 | KT-15 | Sterile electrode | GEI,OUH | Electrosurgical, Cutting & Coagulation & Accessories,Skin Resurfacing Rf Applicator | 2 | INTRAgen Tip | |
| 12 | 08800020105028 | KT-07 | Sterile electrode | OUH,GEI | Skin Resurfacing Rf Applicator,Electrosurgical, Cutting & Coagulation & Accessories | 2 | INTRAgen Tip | |
| 13 | 08800020101211 | KT-15 | INTRAgen Tip (KT-15) | OUH,GEI | Skin Resurfacing Rf Applicator,Electrosurgical, Cutting & Coagulation & Accessories | 2 | INTRAgen Tip | |
| 14 | 08800020100986 | Pumping-49 Tip | GEY | Motor, Surgical Instrument, Ac-Powered | D'Liv Tip | |||
| 15 | 08800020100979 | Pumping-25 Tip | GEY | Motor, Surgical Instrument, Ac-Powered | D'Liv Tip | |||
| 16 | 08800020100962 | Pumping-21 Tip | GEY | Motor, Surgical Instrument, Ac-Powered | D'Liv Tip | |||
| 17 | 08800020100955 | Pumping-16 Tip | GEY | Motor, Surgical Instrument, Ac-Powered | D'Liv Tip | |||
| 18 | 08800020100184 | INTRAcel | Fractional RF Micro Needle System | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | INTRAcel RF Microneedle System | |
| 19 | 08800020100177 | INTRAcel PRO | Fractional RF Micro Needle System | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | INTRAcel RF Microneedle System | |
| 20 | 08800020111135 | S-25 | POTENZA Tip (Sterile micro needle electrode S-25 Tip) | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | POTENZA Tip | |
| 21 | 08800020111272 | A1-15 | POTENZA Tip (Sterile micro needle electrode A1-15 Tip) | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | POTENZA Tip | |
| 22 | 08800020111258 | P1-08 | POTENZA Tip (Sterile micro needle electrode P1-08 Tip) | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | POTENZA Tip | |
| 23 | 08800020111159 | S-16 | POTENZA Tip (Sterile micro needle electrode S-16 tip) | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | POTENZA Tip | |
| 24 | 08800020111142 | I-16 | POTENZA Tip (Sterile micro needle electrode I-16 Tip) | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | POTENZA Tip | |
| 25 | 08800020101136 | A1-12 | A1-12 (FDA/1EA) | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | POTENZA Tip | |
| 26 | 08800020111128 | I-25 | POTENZA Tip (Sterile micro needle electrode I-25 Tip) | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | POTENZA Tip | |
| 27 | 08800020111111 | S-49 | POTENZA Tip (Sterile micro needle electrode S-49 Tip) | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | POTENZA Tip | |
| 28 | 08800020111104 | I-49 | POTENZA Tip (Sterile micro needle electrode I-49 Tip) | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | POTENZA Tip | |
| 29 | 08800020110022 | Edge ONE Arm | Articulated arm | GEX,ONG | Powered Laser Surgical Instrument,Powered Laser Surgical Instrument With Microbe Powered Laser Surgical Instrument,Powered Laser Surgical Instrument With Microbeam\Fractional Output | 2 | Edge ONE Arm | |
| 30 | 08800020106018 | SmoothCool HR | Phototherapy unit | GEX | Powered Laser Surgical Instrument | SmoothCool HR | ||
| 31 | 08800020105011 | INTRAgen | Electrosurgical unit | OUH,GEI | Skin Resurfacing Rf Applicator,Electrosurgical, Cutting & Coagulation & Accessories | 2 | INTRAgen | |
| 32 | 08800020104014 | Edge | CO2 Fractional laser system | ONG | Powered Laser Surgical Instrument With Microbeam\Fractional Output | 2 | Edge | |
| 33 | 08800020103017 | SmoothCool | Phototherapy unit | ONF | Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | 2 | SmoothCool | |
| 34 | 08800020102737 | SmoothCool HR | Unit (FDA) | GEX | Powered Laser Surgical Instrument | 2 | SmoothCool HR | |
| 35 | 08800020102027 | TRI-BEAM Arm | Articulated Arm | GEX | Powered Laser Surgical Instrument | 2 | TRI-BEAM Arm | |
| 36 | 08800020101204 | P1-08 | P1-08 (FDA/1EA) | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | POTENZA Tip | |
| 37 | 08800020101198 | S-16 Tip | S-16 Tip (FDA/1EA) | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | POTENZA Tip | |
| 38 | 08800020101181 | I-16 Tip | I-16 Tip (FDA/1EA) | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | POTENZA Tip | |
| 39 | 08800020101174 | C9 Tip | C9 Tip (FDA/1EA) | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | POTENZA Tip | |
| 40 | 08800020101167 | C21-2 Tip | C21-2 Tip (FDA/1EA) | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | POTENZA Tip | |
| 41 | 08800020101150 | C21-1 Tip | C21-1 Tip (FDA/1EA) | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | POTENZA Tip | |
| 42 | 08800020101143 | A1-15 | A1-15 (FDA/1EA) | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | POTENZA Tip | |
| 43 | 08800020100269 | S-25 Tip | S-25 Tip (FDA/1EA) | GEI | Electrosurgical, Cutting & Coagulation & Accessories | POTENZA Tip | ||
| 44 | 08800020100252 | I-25 Tip | I-25 Tip (FDA/1EA) | GEI | Electrosurgical, Cutting & Coagulation & Accessories | POTENZA Tip | ||
| 45 | 08800020100245 | S-49 Tip | S-49 Tip (FDA/1EA) | GEI | Electrosurgical, Cutting & Coagulation & Accessories | POTENZA Tip | ||
| 46 | 08800020100238 | I-49 Tip | I-49 Tip (FDA/1EA) | GEI | Electrosurgical, Cutting & Coagulation & Accessories | POTENZA Tip | ||
| 47 | 08800020100221 | CP-21 Tip | CP-21 Tip (FDA/1EA) | GEI | Electrosurgical, Cutting & Coagulation & Accessories | POTENZA Tip | ||
| 48 | 08800020100207 | Combo-box | POTENZA Tip (Sterile micro needle electrode Combo-box) | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | POTENZA Tip | |
| 49 | 08800020100191 | CP-21 | POTENZA Tip (Sterile micro needle electrode CP-21 Tip) | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | POTENZA Tip |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 08886479300238 | FG1393 | CAT1394 | The RhinAer® Stylus is a disposable handheld device capable of delivering bipola The RhinAer® Stylus is a disposable handheld device capable of delivering bipolar radiofrequency energy to tissue.The RhinAer® Stylus consists of a handle, shaft and treatment tip. An array of bipolar electrodes is positioned on a non-conductive tip which is attached to a handle via a non-conductive shaft. A temperature sensor is located on the tip to monitor tissue temperature. The Stylus is attached to a temperature-controlled radiofrequency generator via a flexible cable. | RhinAer® Stylus | AERIN MEDICAL INC. |
| 2 | 08886479300214 | MS1198 | 309-05 | The power cord is an accessory for the Aerin Console which is an AC (alternating The power cord is an accessory for the Aerin Console which is an AC (alternating current) radiofrequency generator that incorporates user interface software to control, monitor and regulate RF power delivery to soft tissues via a cable-connected electrosurgical hand piece and electrode. | Power Cord 15 ft (US) | AERIN MEDICAL INC. |
| 3 | 08886479300184 | FG815 | CAT821 | The RhinAer Stylus is a disposable handheld device capable of delivering bipolar The RhinAer Stylus is a disposable handheld device capable of delivering bipolar radiofrequency energy to tissue.The RhinAer Stylus consists of a handle, shaft and treatment tip. An array of bipolar electrodes is positioned on a non-conductive tip which is attached to a handle via a non-conductive shaft. A temperature sensor is located on the tip to monitor tissue temperature. The Stylus is attached to a temperature-controlled radiofrequency generator via a flexible cable. The RhinAer Stylus treats symptoms of chronic rhinitis by modifying the tissues of the nasal airway through the use of low doses of radiofrequency energy to destroy tissue in the posterior nasal nerve regions. The low-power radiofrequency energy generates heat within the submucosal tissue, destroying local tissue, mucous cells, and glands, and creating a coagulation lesion. This destruction of tissue in posterior nasal nerve regions improves symptoms of chronic rhinitis.The RhinAer Stylus tip is temporarily inserted into the nose to access the treatment area. The procedure requires local anesthesia only. | RhinAer Stylus | AERIN MEDICAL INC. |
| 4 | 08886479300160 | FG722 | CAT723 | The VivAer® Stylus is a disposable handheld device capable of delivering bipolar The VivAer® Stylus is a disposable handheld device capable of delivering bipolar radiofrequency energy to tissue. The VivAer® Stylus consists of a handle, shaft and treatment tip. An array of bipolar electrodes is positioned on a nonconductive tip which is attached to a handle via a nonconductive shaft. A temperature sensor is located on the tip to monitor tissue temperature. The Stylus is attached to a Temperature controlled radiofrequency generator (Aerin Console) via a flexible cable. | VivAer® Stylus | AERIN MEDICAL INC. |
| 5 | 08886479300146 | FG257 | CAT410 | The Vivaer ARC Stylus is a disposable handheld device capable of delivering bipo The Vivaer ARC Stylus is a disposable handheld device capable of delivering bipolar radiofrequency energy to tissue. The Vivaer ARC Stylus consists of a handle, shaft and treatment tip. An array of bipolar electrodes is positioned on a non-conductive tip which is attached to a handle via a non-conductive shaft. A temperature sensor is located on the tip to monitor tissue temperature. The Stylus is intended to attach to a temperature-controlled radiofrequency generator (Aerin Console) via a flexible cable. | Vivaer ARC Stylus | AERIN MEDICAL INC. |
| 6 | 08886479300139 | CAT307 | CAT307 | The foot switch is an accessory for use with the Aerin Console which is an AC (a The foot switch is an accessory for use with the Aerin Console which is an AC (alternating current) radiofrequency generator that incorporates user interface software to control, monitor and regulate RF power delivery to soft tissues via a cable-connected electrosurgical hand piece and electrode. | Foot Switch | AERIN MEDICAL INC. |
| 7 | 08886479300115 | CAT309-02 | CAT309-02 | The power cord is an accessory for the Aerin Console which is an AC (alternating The power cord is an accessory for the Aerin Console which is an AC (alternating current) radiofrequency generator that incorporates user interface software to control, monitor and regulate RF power delivery to soft tissues via a cable-connected electrosurgical hand piece and electrode. | Power Cord | AERIN MEDICAL INC. |
| 8 | 08886479300047 | CAT305 | CAT305-02 | The Aerin Console Set consists of the following items: 1) Aerin Console unit, 2) The Aerin Console Set consists of the following items: 1) Aerin Console unit, 2) Power Cord, 3) Foot Switch.The Aerin Console is an AC (alternating current) radiofrequency generator. It incorporates user interface software to control, monitor and regulate RF power delivery to soft tissues via a cable-connected electrosurgical hand piece and electrode. | Aerin Console Set | AERIN MEDICAL INC. |
| 9 | 08886479300030 | FG226 | CAT305 | The Aerin Console is an AC (alternating current) radiofrequency generator. It in The Aerin Console is an AC (alternating current) radiofrequency generator. It incorporates user interface software to control, monitor and regulate RF power delivery to soft tissues via a cable-connected electrosurgical hand piece and electrode. The Aerin Console Set consists of the following items: 1) Aerin Console unit, 2) Power Cord, 3) Foot Switch and is intended for use with one or more Aerin Styli. | Aerin Console | AERIN MEDICAL INC. |
| 10 | 08886479300023 | FG256 | CAT409 | The InSeca ARC Stylus is a disposable handheld device capable of delivering bipo The InSeca ARC Stylus is a disposable handheld device capable of delivering bipolar radiofrequency energy to tissue. The InSeca ARC Stylus consists of a handle, shaft and treatment tip. An array of bipolar electrodes is positioned on a non-conductive tip which is attached to a handle via a non-conductive shaft. A temperature sensor is located on the tip to monitor tissue temperature. The Stylus is attached to a temperature-controlled radiofrequency generator (Aerin Console) via a flexible cable. | InSeca ARC Stylus | AERIN MEDICAL INC. |
| 11 | 08809559960306 | RFTP-0710LN | The RFT electrode is sterile single use mono-polar electrode for electrosurgical unit. | RFT Electrode | RF MEDICAL CO.,LTD. | |
| 12 | 08809559960290 | RFTP-0707LN | The RFT electrode is sterile single use mono-polar electrode for electrosurgical unit. | RFT Electrode | RF MEDICAL CO.,LTD. | |
| 13 | 08809559960283 | RFTP-0705LN | The RFT electrode is sterile single use mono-polar electrode for electrosurgical unit. | RFT Electrode | RF MEDICAL CO.,LTD. | |
| 14 | 08809559960146 | RFTP 1015N | THYBLATE™ | RF MEDICAL CO.,LTD. | ||
| 15 | 08809559960139 | RFTP-1010N | The RFT electrode is sterile single use mono-polar electrode for electrosurgical unit. | RFT Electrode | RF MEDICAL CO.,LTD. | |
| 16 | 08809559960078 | RFTP-0710N | The RFT electrode is sterile single use mono-polar electrode for electrosurgical unit. | RFT Electrode | RF MEDICAL CO.,LTD. | |
| 17 | 08809559960061 | RFTP-0707N | The RFT electrode is sterile single use mono-polar electrode for electrosurgical unit. | RFT Electrode | RF MEDICAL CO.,LTD. | |
| 18 | 08809502330187 | F/S-B | Foot switch | VIOL CO.,LTD. | ||
| 19 | 08809502330170 | P/B | Handpiece | VIOL CO.,LTD. | ||
| 20 | 08809502330163 | J18BS | XW18 | VIOL CO.,LTD. | ||
| 21 | 08809502330156 | J25BS | XA25 | VIOL CO.,LTD. | ||
| 22 | 08809502330149 | J25BM | XE25 | VIOL CO.,LTD. | ||
| 23 | 08809502330101 | SYLFIRM X | SYLFIRM X | VIOL CO.,LTD. | ||
| 24 | 08809502330088 | SCARLET SRF | SCARLET SRF | VIOL CO.,LTD. | ||
| 25 | 08809502330040 | H/S_02 | HAND PIECE | VIOL CO.,LTD. | ||
| 26 | 08809502330033 | F/S | FOOT SWITCH | VIOL CO.,LTD. | ||
| 27 | 08809502330026 | CELFIRM | CELFIRM | VIOL CO.,LTD. | ||
| 28 | 08809447653280 | GENIUS M HANDPIECE_LUTRONIC GENIUS | GENIUS M HANDPIECE | LUTRONIC GENIUS | LUTRONIC CORPORATION | |
| 29 | 08809447653266 | P16D TIP Lutronic GENIUS | P16D(4*4) TIP Lutronic GENIUS | LUTRONIC GENIUS | LUTRONIC CORPORATION | |
| 30 | 08809447653242 | P14D TIP Lutronic GENIUS | P14D(2*7) TIP Lutronic GENIUS | LUTRONIC GENIUS | LUTRONIC CORPORATION | |
| 31 | 08809447653228 | M49D TIP Lutronic GENIUS | M49D(7*7) TIP Lutronic GENIUS Macro size | LUTRONIC GENIUS | LUTRONIC CORPORATION | |
| 32 | 08809447652405 | Lutronic Genius Operator's Manual Korea | Lutronic Genius Operator's Manual Korea | LUTRONIC GENIUS | LUTRONIC CORPORATION | |
| 33 | 08809447652399 | 16 pin Tip (Optional) 1 ea | 16 pin Tip (Optional) 1 ea | INFINI | LUTRONIC CORPORATION | |
| 34 | 08809447652375 | 49 pin Tip (Standard) 1 ea | 49 pin Tip (Standard) 1 ea | INFINI | LUTRONIC CORPORATION | |
| 35 | 08809447652351 | 49 pin (Enhanced) 1 ea | 49 pin (Enhanced) 1 ea | INFINI | LUTRONIC CORPORATION | |
| 36 | 08809447652290 | Handpiece Holder | Handpiece Holder (Accessary) | N/A | LUTRONIC CORPORATION | |
| 37 | 08809447652283 | HANDPIECE_LUTRONIC GENIUS | HANDPIECE ASSY_LUTRONIC GENIUS | N/A | LUTRONIC CORPORATION | |
| 38 | 08809447652276 | G49D TIP(200, 0.5) Lutronic GENIUS | G49D TIP(200, 0.5) Lutronic GENIUS (멸균) | N/A | LUTRONIC CORPORATION | |
| 39 | 08809447652252 | Lutronic Genius Operator's Manual USA | Lutronic Genius Operator's Manual USA | N/A | LUTRONIC CORPORATION | |
| 40 | 08809447652238 | GENIUS G U110V | LUTRONIC GENIUS | LUTRONIC CORPORATION | ||
| 41 | 08809447652214 | Handpiece cradle | Handpiece cable hanger | N/A | LUTRONIC CORPORATION | |
| 42 | 08809447652207 | AC POWER CABLE | AC POWER CABLE 3m (GENIUS) | N/A | LUTRONIC CORPORATION | |
| 43 | 08809447652139 | Patient Goggle | Patient Goggle for INFINI | N/A | LUTRONIC CORPORATION | |
| 44 | 08809447651781 | TIP A-49 1 ea | INFINI MFR TIP A-49 1 ea(MFR 49 Tip) | N/A | LUTRONIC CORPORATION | |
| 45 | 08809447651170 | INFINI Operator's Manual USA | INFINI Operator's Manual USA (Operator's Manual) | N/A | LUTRONIC CORPORATION | |
| 46 | 08809447651064 | TIP A-16 1 ea | INFINI TIP A-16 1 ea (MFR 16 Tip) | N/A | LUTRONIC CORPORATION | |
| 47 | 08809447651033 | MFR 49 TIP II 1 ea | INFINI MFR 49 TIP II 1 ea(MFR 49 Tip) | N/A | LUTRONIC CORPORATION | |
| 48 | 08809447651019 | Handpiece cradle | INFINI Handpiece cradle stand assy (Handpiece cradle) | N/A | LUTRONIC CORPORATION | |
| 49 | 08809447650982 | MFR Handpiece | INFINI MFR Handpiece (MFR Handpiece) | N/A | LUTRONIC CORPORATION | |
| 50 | 08809447650883 | INFINI MFR G U110V | INFINI MFR G U110V (INFINI Radiofrequency System) | INFINI | LUTRONIC CORPORATION |