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 4 of 29
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K211979 | Lumenis Y&R Laser System | Lumenis, Inc. | 2022-06-21 | Traditional | PDF ↗ |
| K212663 | HELIOS IV 785 | Laseroptek Co., Ltd. | 2022-06-09 | Traditional | PDF ↗ |
| K213261 | EpilME | Neauvia North America | 2022-06-02 | Traditional | PDF ↗ |
| K214049 | Leaseir MHR Xcell | Leaseir Technologies, Slu | 2022-06-02 | Traditional | PDF ↗ |
| K220793 | InnoVoyce Laser Fiber | Innovoyce, LLC | 2022-05-25 | Traditional | PDF ↗ |
| K220381 | Diode Laser Therapy Systems | Beijing Lasertell Medical Co., Ltd. | 2022-05-20 | Traditional | PDF ↗ |
| K211534 | RevoLix HTL | Lisa Laser Products GmbH | 2022-05-19 | Traditional | PDF ↗ |
| K220467 | The Family of UltraPulse CO2 Surgical and Aesthetic Lasers, Delivery Devices and Accessories | Lumenis Be, Ltd. | 2022-05-18 | Traditional | PDF ↗ |
| K220041 | HandPICO | Vydence Medical Industria E Comercio Ltda | 2022-05-05 | Traditional | PDF ↗ |
| K213594 | ECHOLASER X4 | Elesta S.P.A | 2022-05-03 | Traditional | PDF ↗ |
| K220189 | LISA Laser Surgical Fibers | Omni-Guide Holdings, Inc. | 2022-04-29 | Traditional | PDF ↗ |
| K213889 | PicoStar | Asclepion Laser Technologies GmbH | 2022-04-22 | Traditional | PDF ↗ |
| K210183 | Waterlase iPLus | Biolase, Inc. | 2022-04-21 | Traditional | PDF ↗ |
| K213484 | SmoothCool HR System | Jeisys Medical, Inc. | 2022-04-20 | Special | PDF ↗ |
| K213350 | mJOULE System and Accessories | Sciton, Inc | 2022-04-15 | Traditional | PDF ↗ |
| K210634 | MCL 31 Dermablate System | Asclepion Laser Technologies GmbH | 2022-04-13 | Traditional | PDF ↗ |
| K220103 | LED Therapy Device (Planar LED/Planar LED mini) | Shenzhen Leaflife Technology Co., Ltd. | 2022-04-12 | Traditional | PDF ↗ |
| K213557 | Finexel | SNJ Co., Ltd. | 2022-04-12 | Traditional | PDF ↗ |
| K213461 | AviClear Laser System | Cutera, Inc. | 2022-03-24 | Traditional | PDF ↗ |
| K220426 | Fiber Dust PRO | Quanta System Spa | 2022-03-16 | Special | PDF ↗ |
| K211722 | Laser treatment system , models Nyx plus, Grace plus, Nemesis, Ares | Canadian Pioneer Medical Technology Corporation | 2022-02-25 | Traditional | PDF ↗ |
| K220020 | Cryo 7 | Zimmer Medizinsysteme GmbH | 2022-02-04 | Special | PDF ↗ |
| K213569 | HOLLYWOOD SPECTRA Laser System | Lutronic Corporation | 2022-02-04 | Traditional | PDF ↗ |
| K211228 | Rosso | Quanta System Spa | 2022-02-02 | Traditional | PDF ↗ |
| K213554 | Sentient Manufacturing Laser Fiber | Sentient Manufacturing , LLC | 2022-02-02 | Traditional | PDF ↗ |
| K212611 | CO2 Laser Equipment | Beijing Globalipl Development Co., Ltd. | 2022-02-01 | Traditional | PDF ↗ |
| K203395 | Platform treatment system | Shanghai Apolo Medical Technology Co., Ltd. | 2022-01-28 | Traditional | PDF ↗ |
| K212478 | Dermatological diode laser system | Beijing Stelle Laser Technology Co., Ltd. | 2022-01-14 | Traditional | PDF ↗ |
| K212127 | Picocaremajesty | Wontech Co., Ltd. | 2022-01-07 | Traditional | PDF ↗ |
| K213225 | Diode Laser System GP900A8, Diode Laser System GP900Q8 | Shenzhen Gsd Tech Co., Ltd. | 2021-12-22 | Traditional | PDF ↗ |
| K212492 | Frax 1940 for Nordlys and Frax Pro | Candela Corporation | 2021-12-20 | Traditional | PDF ↗ |
| K202848 | S2 Pigment Removal System | Lightsense Technologies, Ltd. | 2021-12-14 | Traditional | PDF ↗ |
| K210847 | UltraClear Fractional Laser System | Fa International, LP | 2021-12-10 | Traditional | PDF ↗ |
| K212573 | PicoLO Premium | Laseroptek Co., Ltd. | 2021-12-08 | Special | PDF ↗ |
| K202175 | OxyLight 2.0 | Raja Trading Company, Inc. | 2021-12-02 | Traditional | PDF ↗ |
| K202288 | Finebeam | SNJ Co., Ltd. | 2021-11-19 | Traditional | PDF ↗ |
| K212607 | Darwin | Luvo Medical Technologies, Inc. | 2021-11-15 | Traditional | PDF ↗ |
| K212978 | Diode laser therapy system | Beijing Unt Technology Co., Ltd. | 2021-11-10 | Traditional | PDF ↗ |
| K211517 | Optica XT Thulium Fiber Laser and Accessories, also known as Optica XT, Optica XT Thulium Fiber Laser, Thulium Fiber Laser 1940 nm, Optica XT Thulium Fiber Laser 1940 nm, Optica XT 60 Thulium Fiber Laser 1940 nm, Optica XT Superpulse Thulium Fiber Laser 1940 nm, OptiLITE Laser Fibers and Accessories | Convergent Laser Technologies | 2021-11-09 | Traditional | PDF ↗ |
| K212502 | Resonic Rapid Acoustic Pulse Device | Soliton, Inc. | 2021-11-05 | Traditional | PDF ↗ |
| K202998 | Vydence Zye and Vydence One | Vydence Medical Industria E Comercio Ltda | 2021-10-26 | Traditional | PDF ↗ |
| K211977 | Medical Diode Laser Systems | Wuhan Dimed Laser Technology Co., Ltd. | 2021-10-26 | Traditional | PDF ↗ |
| K212793 | Laser Treatment System, Model: Hera, Armo | Canadian Pioneer Medical Technology Corporation | 2021-10-25 | Traditional | PDF ↗ |
| K211735 | CO2 Laser Machine, Model: BW-203B | Zhengzhou Bestview ST Co., Ltd. | 2021-10-22 | Traditional | PDF ↗ |
| K212270 | DEKA LipoAI | El.En Electronic Engineering Spa | 2021-10-21 | Traditional | PDF ↗ |
| K201773 | PICOHI | Hironic Co., Ltd. | 2021-10-19 | Traditional | PDF ↗ |
| K212703 | AcuPulse CO2 Laser System, Delivery Devices and Accessories | Lumenis, Ltd. | 2021-10-19 | Traditional | PDF ↗ |
| K212082 | Picore | Bio-Med USA, Inc. | 2021-10-06 | Special | PDF ↗ |
| K203799 | ProFlex CO2 Laser Fiber | Innovaquartz, LLC | 2021-09-20 | Traditional | PDF ↗ |
| K211637 | AROMA GRAND | Daeju Meditech Engineering Co., Ltd. | 2021-09-03 | Traditional | PDF ↗ |
| K210951 | Leonardo Mini Blue | Ceramoptec GmbH | 2021-09-01 | Abbreviated | PDF ↗ |
| K211362 | SCAR 3 | El.En Electronic Engineering Spa | 2021-08-25 | Traditional | PDF ↗ |
| K211761 | UltraLase Flexible CO2 Laser Waveguide | W & R Investments, LLC Dba Laser Engineering | 2021-07-30 | Special | PDF ↗ |
| K211335 | Diode Laser Machine, Model Number: BM-100 | Zhengzhou Bestview ST Co., Ltd. | 2021-07-28 | Traditional | PDF ↗ |
| K203728 | Darwin | Luvo Medical Technologies, Inc. | 2021-07-14 | Traditional | PDF ↗ |
| K211821 | DEKA Motus AZ | El.En Electronic Engineering Spa | 2021-07-06 | Special | PDF ↗ |
| K203441 | The Alma Hybrid Laser System | Alma Lasers , Ltd. | 2021-07-02 | Traditional | PDF ↗ |
| K202991 | Fotona XPulse Pro Laser Platform | Fotona D.O.O. | 2021-06-22 | Traditional | PDF ↗ |
| K202828 | Surgical Green Laser System | Realton (Suzhou) Medical Technology Co., Ltd. | 2021-06-04 | Traditional | PDF ↗ |
| K211401 | SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) | Gyrus Acmi, Inc. | 2021-06-03 | Special | PDF ↗ |
| K210535 | UltraLight LED System | Rohrer Aesthetics, LLC | 2021-05-24 | Traditional | PDF ↗ |
| K210168 | Diode Laser Therapy Systems | Beijing Kes Biology Technology Co., Ltd. | 2021-05-10 | Traditional | PDF ↗ |
| K210925 | Flexiva Pulse Laser Fiber, Flexiva Pulse Tractip Laser Fiber, Flexiva Pulse ID Laser Fiber, Flexiva Pulse ID TracTip Laser Fiber | Boston Scientific | 2021-04-28 | Traditional | PDF ↗ |
| K210964 | Resonic Rapid Acoustic Pulse Device | Soliton, Inc. | 2021-04-27 | Special | PDF ↗ |
| K210663 | Dermatological Diode Laser Systems | Beijing HuaCheng Taike Technology Co., Ltd. | 2021-04-26 | Traditional | PDF ↗ |
| K202258 | ERISE Laser handpiece | El.En Electronic Engineering Spa | 2021-04-26 | Traditional | PDF ↗ |
| K202043 | Secret Duo | Ilooda Co,., Ltd. | 2021-04-23 | Traditional | PDF ↗ |
| K202257 | Dermatological Diode Laser Systems | Zhuolu Jontelaser Manufacturing Technology Co., Ltd. | 2021-04-23 | Traditional | PDF ↗ |
| K203491 | PicoLO Nd: YAG Picosecond Laser System | Laseroptek Co., Ltd. | 2021-04-07 | Special | PDF ↗ |
| K201171 | LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe Disposable | Leoni Fiber Optics, Inc. | 2021-04-02 | Traditional | PDF ↗ |
| K210226 | PicoSure Workstation | Cynosure, LLC | 2021-03-30 | Traditional | PDF ↗ |
| K201466 | Tranberg CLS Laser Applicator | Clinical Laserthermia Systems, AB | 2021-03-26 | Traditional | PDF ↗ |
| K203788 | DermaV Laser System | Lutronic Corporation | 2021-03-26 | Traditional | PDF ↗ |
| K202985 | LightWalker Laser System Family | Fotona D.O.O. | 2021-03-19 | Traditional | PDF ↗ |
| K210142 | Fiber Dust | Quanta System Spa | 2021-03-11 | Traditional | PDF ↗ |
| K203054 | FlexSys | Gme German Medical Engineering GmbH | 2021-03-05 | Traditional | PDF ↗ |
| K210033 | Laser Treatment System, Model: NYX and Grace | Canadian Pioneer Medical Technology Corporation | 2021-02-26 | Traditional | PDF ↗ |
| K202702 | FLARE Single-Use Surgical Laser Fiber | Realton (Suzhou) Medical Technology Co., Ltd. | 2021-02-26 | Traditional | PDF ↗ |
| K203804 | Global Med Systems Milesman Compact Laser | Global Med Systems SL | 2021-02-23 | Traditional | PDF ↗ |
| K201801 | Rapid Acoustic Pulse Device | Soliton, Inc. | 2021-01-29 | Traditional | PDF ↗ |
| K193266 | MIIN | Medico USA, Inc. | 2021-01-22 | Traditional | PDF ↗ |
| K203241 | OmniGuide BeamPath OTO-U Fiber | Omniguide, Inc. | 2021-01-14 | Special | PDF ↗ |
| K203544 | UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories | Lumenis, Ltd. | 2020-12-24 | Special | PDF ↗ |
| K201594 | Primelase Excellence | High Technology Products S.L.U | 2020-12-17 | Traditional | PDF ↗ |
| K202601 | Single-use Sterile medical laser fiber | Realton (Suzhou) Medical Technology Co., Ltd. | 2020-12-15 | Traditional | PDF ↗ |
| K201687 | Avenda Health Treatment System | Avenda Health, Inc. | 2020-11-30 | Traditional | PDF ↗ |
| K202250 | Dermatological Carbon Dioxide Laser Systems | Zhuolu Jontelaser Manufacturing Technology Co., Ltd. | 2020-11-25 | Traditional | PDF ↗ |
| K200693 | K2 MOBILE | Hulaser, Inc. | 2020-11-19 | Traditional | PDF ↗ |
| K202980 | Laser Therapy Device | Shenzhen Leaflife Technology Co., Ltd. | 2020-11-19 | Traditional | PDF ↗ |
| K202172 | StarWalker | Fotona D.O.O. | 2020-11-19 | Traditional | PDF ↗ |
| K202503 | Chrome | Quanta System Spa | 2020-11-18 | Traditional | PDF ↗ |
| K202758 | Nd: YAG Laser Therapy Systems HM-YL900 | Shangdong Huamei Technology Co., Ltd. | 2020-11-16 | Traditional | PDF ↗ |
| K202428 | AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories | Lumenis, Ltd. | 2020-10-22 | Special | PDF ↗ |
| K202041 | Opera Evo | Quanta System Spa | 2020-10-15 | Traditional | PDF ↗ |
| K201056 | NeuroBlate System | Monteris Medical, Inc. | 2020-08-21 | Traditional | PDF ↗ |
| K201406 | Picowon | Wontech Co., Ltd. | 2020-07-22 | Traditional | PDF ↗ |
| K201663 | AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories | Lumenis, Ltd. | 2020-07-16 | Special | PDF ↗ |
| K201109 | CO2 Laser Therapy System | Shanghai Apolo Medical Technology Co., Ltd. | 2020-07-15 | Traditional | PDF ↗ |
| K201455 | Litho 150, Cyber Ho 150 | Quanta System Spa | 2020-06-30 | Special | PDF ↗ |
| K200736 | Stardust Med | I.T.S. Group S.R.L. | 2020-06-26 | Traditional | PDF ↗ |
Product code GEX · Class II · General, Plastic Surgery. Data: openFDA.