FDA Product Code
FDA Product Code GEX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4810
510(k) Clearances — 2,887 records · page 5 of 29
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K193477 | Nd: YAG Laser Therapy Systems | Beijing Kes Biology Technology Co., Ltd. | 2020-06-24 | Traditional | PDF ↗ |
| K200042 | CO2 Laser System | Beijing Superlaser Technology Co., Ltd. | 2020-06-09 | Traditional | PDF ↗ |
| K200786 | Venus Epileve | Venus Concept USA, Inc. | 2020-06-09 | Traditional | PDF ↗ |
| K200104 | Oxylight | Raja Trading Company, Inc. | 2020-06-04 | Traditional | PDF ↗ |
| K200116 | PicoSecond Nd: YAG Laser System | Shanghai Apolo Medical Technology Co., Ltd. | 2020-05-28 | Traditional | PDF ↗ |
| K200525 | Medical Diode Laser Hair Removal System | Weifang Mingliang Electronics Co., Ltd. | 2020-05-27 | Traditional | PDF ↗ |
| K201111 | GentleMax Pro Plus | Candela Corporation | 2020-05-26 | Special | PDF ↗ |
| K200751 | Photodynamic Therapy (PDT) Equipment | Shangdong Huamei Technology Co., Ltd. | 2020-05-21 | Traditional | PDF ↗ |
| K200659 | Dermalux Tri-Wave MD | Aesthetic Technology, Ltd. | 2020-05-09 | Traditional | PDF ↗ |
| K192856 | MT One | M&T S.R.L. | 2020-04-24 | Traditional | PDF ↗ |
| K200118 | Diode Laser Therapy Device | Shanghai Apolo Medical Technology Co., Ltd. | 2020-04-17 | Traditional | PDF ↗ |
| K193464 | ND:YAG Laser | Beijing Superlaser Technology Co., Ltd. | 2020-04-13 | Traditional | PDF ↗ |
| K191970 | Diode Laser Hair Removal System | Beijing Sano Laser S&T Development Co.,Ltd | 2020-04-06 | Traditional | PDF ↗ |
| K192735 | Diode Laser Hair Removal Machine | Beijing Lead Beauty S & T Co., Ltd. | 2020-04-03 | Traditional | PDF ↗ |
| K193656 | SkyPulse | Fotona D.O.O. | 2020-03-27 | Traditional | PDF ↗ |
| K192951 | Ellipse Frax 1940 for Ellipse Nordlys and Ellipse Ydun | Ellipse A/S | 2020-03-26 | Traditional | PDF ↗ |
| K193661 | LightWalker Laser System Family | Fotona D.O.O. | 2020-03-25 | Traditional | PDF ↗ |
| K193609 | Q Switched Nd: YAG Laser machine | Beijing Lead Beauty S & T Co., Ltd. | 2020-03-20 | Traditional | PDF ↗ |
| K192272 | Wolf445nm | A.R.C Laser GmbH | 2020-03-17 | Traditional | PDF ↗ |
| K200110 | SANDRO Dual | Wontech Co., Ltd. | 2020-03-16 | Traditional | PDF ↗ |
| K193486 | Epic 980 | Biolase, Inc. | 2020-03-16 | Traditional | PDF ↗ |
| K192483 | MeDioStar | Asclepion Laser Technologies GmbH | 2020-03-13 | Special | PDF ↗ |
| K193367 | elysion-pro | High Technology Products S.L.U | 2020-03-12 | Traditional | PDF ↗ |
| K193446 | Bare: 808 | Luvo Medical Technologies, Inc. | 2020-03-10 | Traditional | PDF ↗ |
| K200331 | Rapid Acoustic Pulse Device | Soliton, Inc. | 2020-03-10 | Special | PDF ↗ |
| K193426 | Elite iQ | Cynosure, LLC | 2020-03-09 | Traditional | PDF ↗ |
| K200234 | Surgical laser fibers | Quanta System Spa | 2020-02-25 | Special | PDF ↗ |
| K192600 | Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60 | Quanta System Spa | 2020-02-21 | Special | PDF ↗ |
| K192617 | Gemini 810+980 Soft Tissue Laser | Azena Medical, LLC | 2020-02-20 | Traditional | PDF ↗ |
| K192583 | PicoLazer Laser System | Rohrer Aesthetics, LLC | 2020-01-17 | Traditional | PDF ↗ |
| K193500 | Stellar M22 for Intense Pulsed Light (IPL) and Laser System | Lumenis, Ltd. | 2020-01-16 | Special | PDF ↗ |
| K193478 | XTRAC Momentum Excimer Laser System | Strata Skin Sciences, Inc. | 2020-01-14 | Special | PDF ↗ |
| K191501 | PALLAS 308/311 Solid-State UV Laser System | Laseroptek Co., Ltd. | 2020-01-03 | Special | PDF ↗ |
| K193375 | NeuroBlate System | Monteris Medical, | 2020-01-03 | Special | PDF ↗ |
| K192755 | Soli-Lite LG4 Galileo | Silhouet-Tone Corporation | 2019-12-20 | Traditional | PDF ↗ |
| K192990 | Litho Evo | Quanta System Spa | 2019-12-20 | Traditional | PDF ↗ |
| K192539 | Deka Luxea | El.En Electronic Engineering Spa | 2019-12-16 | Traditional | PDF ↗ |
| K192569 | Diode Laser Therapy System | San HE Lefis Electronics Co., Ltd. | 2019-12-13 | Traditional | PDF ↗ |
| K192516 | Diode Laser 808nm | Beijing Superlaser Technology Co., Ltd. | 2019-12-10 | Traditional | PDF ↗ |
| K191962 | Vitra 2 | Quantel Medical | 2019-12-05 | Traditional | PDF ↗ |
| K192430 | Epic 980 | Biolase, Inc. | 2019-12-04 | Special | PDF ↗ |
| K192528 | CO2 Laser Therapy System | Shangdong Huamei Technology Co., Ltd. | 2019-12-03 | Traditional | PDF ↗ |
| K192269 | TwinScan 808/755 Laser System | Gme German Medical Engineering GmbH | 2019-11-19 | Traditional | PDF ↗ |
| K192331 | LaseMD LEO Laser System | Lutronic Global | 2019-11-12 | Traditional | PDF ↗ |
| K191693 | BC-5 | Reveallux, Corp | 2019-11-01 | Abbreviated | PDF ↗ |
| K191942 | MT One Diamond | M&T S.R.L. | 2019-10-17 | Traditional | PDF ↗ |
| K190319 | Waterlase Laser System Family | Biolase, Inc. | 2019-10-10 | Traditional | PDF ↗ |
| K191842 | Discovery Pico, Discovery Pico Plus, Discovery Pico Derm | Quanta System Spa | 2019-09-17 | Traditional | PDF ↗ |
| K191685 | PicoWay Laser System | Candela Corporation | 2019-09-16 | Traditional | PDF ↗ |
| K191518 | CO2 Laser System | Shenzhen Gsd Tech Co., Ltd. | 2019-09-12 | Traditional | PDF ↗ |
| K181614 | Sterling Supreme Diode Laser | CAO Group, Inc. | 2019-09-10 | Traditional | PDF ↗ |
| K181602 | Pioneer Elite Diode Laser | CAO Group, Inc. | 2019-09-10 | Traditional | PDF ↗ |
| K181601 | Precise SHP Diode Laser | CAO Group, Inc. | 2019-09-09 | Traditional | PDF ↗ |
| K192160 | EVO Platform | Quanta System Spa | 2019-09-06 | Special | PDF ↗ |
| K183563 | Holinwon 30 | Wontech Co., Ltd. | 2019-09-05 | Traditional | PDF ↗ |
| K191554 | LightWalker Laser System Family | Fotona D.O.O. | 2019-08-30 | Traditional | PDF ↗ |
| K183122 | 810nm Diode Laser System | Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd | 2019-08-25 | Traditional | PDF ↗ |
| K191349 | 980nm Diode Laser Therapy Device | Shanghai Apolo Medical Technology Co., Ltd. | 2019-08-16 | Traditional | PDF ↗ |
| K183647 | SOLTIVE Laser System(SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVELaser Fibers, and Accessories) | Olympus Surgical Technologies America | 2019-08-09 | Traditional | PDF ↗ |
| K191321 | Primelase Excellence | High Technology Products S.L.U | 2019-08-02 | Traditional | PDF ↗ |
| K191611 | Diode Laser Therapy Systems | Wingderm Electro-Optics , Ltd. | 2019-07-31 | Traditional | PDF ↗ |
| K182930 | PerioLase Nd:YAG Pulsed Dental Laser System | Millennium Dental Technologies, Inc. | 2019-07-12 | Traditional | PDF ↗ |
| K191162 | EpiLaze Multi-wavelength Laser | Rohrer Aesthetics, LLC | 2019-07-09 | Traditional | PDF ↗ |
| K190938 | Phototherapy System | Shanghai Apolo Medical Technology Co., Ltd. | 2019-06-26 | Traditional | PDF ↗ |
| K190936 | Q-Switched Nd: YAG Laser System | Shanghai Apolo Medical Technology Co., Ltd. | 2019-06-17 | Traditional | PDF ↗ |
| K183566 | CLARITY II Laser System | Lutronic Corporation | 2019-06-14 | Traditional | PDF ↗ |
| K190542 | Soliton Acoustic Wave Device | Soliton, Inc. | 2019-05-24 | Traditional | PDF ↗ |
| K183199 | TRIO Handpiece | Omniguide, Inc. | 2019-05-02 | Traditional | PDF ↗ |
| K183156 | V-Laser | Wontech Co., Ltd. | 2019-04-24 | Traditional | PDF ↗ |
| K182924 | Diode Laser Treatment System | Weifang KM Electronics Co., Ltd. | 2019-04-15 | Traditional | PDF ↗ |
| K190392 | WaveLight FS200 Patient Interface | Alcon Laboratories, Inc. | 2019-03-26 | Special | PDF ↗ |
| K182173 | Joule System | Sciton, Inc | 2019-03-06 | Traditional | PDF ↗ |
| K190007 | Vydence Laser Family | Vydence Medical Industria E Comercio Ltda | 2019-03-01 | Traditional | PDF ↗ |
| K183452 | Vbeam Prima Laser System | Candela Corp. | 2019-02-01 | Special | PDF ↗ |
| K183392 | PicoLO Nd:YAG Picosecond Laser System | Laseroptek Co., Ltd. | 2019-01-04 | Traditional | PDF ↗ |
| K182045 | Lotus III Multi-Pulsed Er: Yag Laser System | Laseroptek Co., Ltd. | 2018-12-27 | Traditional | PDF ↗ |
| K182997 | enlighten III Laser System | Cutera, Inc. | 2018-12-12 | Traditional | PDF ↗ |
| K183307 | Magma Spark Pro (Magma Spark Plus, Alpha) | Formatk Systems , Ltd. | 2018-12-11 | Special | PDF ↗ |
| K182831 | SabreLine and SabreGuard Laser Fibers | Coloplast Corp. | 2018-12-10 | Traditional | PDF ↗ |
| K182663 | Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System | Finemec Co., Ltd. | 2018-11-30 | Traditional | PDF ↗ |
| K182604 | New Era | Step UP Skin Laser, LLC | 2018-11-14 | Traditional | PDF ↗ |
| K182270 | Cellene CO2 Laser System | Bio-Med USA, Inc. | 2018-11-02 | Traditional | PDF ↗ |
| K182088 | XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP Spectro | Fotona D.O.O. | 2018-10-31 | Traditional | PDF ↗ |
| K182669 | Youlaser CO2 | Quanta System Spa | 2018-10-17 | Special | PDF ↗ |
| K182036 | NeuroBlate System | Monteris Medical, | 2018-10-15 | Traditional | PDF ↗ |
| K181867 | Deka Smartxide2 Trio | El.En Electronic Engineering Spa | 2018-10-02 | Special | PDF ↗ |
| K181632 | Venacure 1470 Pro | Quanta System Spa | 2018-09-17 | Traditional | PDF ↗ |
| K173827 | LightScalpel | Lightscalpel, LLC | 2018-09-14 | Traditional | PDF ↗ |
| K173676 | A-FIT | Hironic Co., Ltd. | 2018-09-14 | Traditional | PDF ↗ |
| K181662 | Iridex TruFocus LIO Premiere | Iridex Corporation | 2018-09-05 | Special | PDF ↗ |
| K181510 | ECHOLASER X4 | El.En Electronic Engineering Spa | 2018-09-04 | Traditional | PDF ↗ |
| K181486 | DEKA Motus AY | El.En Electronic Engineering Spa | 2018-08-30 | Traditional | PDF ↗ |
| K181480 | MMD Tip | Strata Skin Sciences, Inc. | 2018-08-01 | Traditional | PDF ↗ |
| K181272 | Picocare Family | Wontech Co., Ltd. | 2018-07-31 | Special | PDF ↗ |
| K181431 | Laser Ureteral Catheter | Cook Incorporated | 2018-07-30 | Traditional | PDF ↗ |
| K180518 | GME LinScan Lite 808 Laser System | Gme German Medical Engineering GmbH | 2018-07-23 | Traditional | PDF ↗ |
| K181019 | Diode Laser System | Guangzhou Huafei Tongda Technology Co., Ltd. | 2018-07-16 | Traditional | PDF ↗ |
| K181523 | Syneron CO2RE System | Syneron-Candela Corp | 2018-07-11 | Special | PDF ↗ |
| K180967 | Dental Diode Laser System | Lazon Medical Laser Co., Ltd. | 2018-07-11 | Traditional | PDF ↗ |
| K173359 | Fractional CO2 Surgical Laser System | Ami, Inc. | 2018-07-05 | Traditional | PDF ↗ |
Product code GEX · Class II · General, Plastic Surgery. Data: openFDA.