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 3 of 29
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K234104 | PICOANDY (Q-Switched Nd:YAG Laser) | Wontech Co., Ltd. | 2024-03-15 | Traditional | PDF ↗ |
| K240497 | Smartxide Tetra Pro | El.En S.P.A. | 2024-03-12 | Special | PDF ↗ |
| K240132 | EmoLED (v. 2-USA) | Emoled, Srl | 2024-03-12 | Traditional | PDF ↗ |
| K240396 | Elite iQ PRO (M122K1) | Cynosure, LLC | 2024-03-08 | Special | PDF ↗ |
| K231876 | MultiPulse HoPLUS | Asclepion Laser Technologies GmbH | 2024-02-22 | Traditional | PDF ↗ |
| K231896 | Diode Laser Therapy System | Beijing Adss Development Co., Ltd. | 2024-02-20 | Traditional | PDF ↗ |
| K231514 | Azure | Daeshin Enterprise Co., Ltd. | 2024-02-14 | Traditional | PDF ↗ |
| K233024 | Alma Harmony | Alma Lasers, Inc. | 2024-02-08 | Traditional | PDF ↗ |
| K233416 | Cryojet Plus (SHE-ACP001-1) | Beijing Sano Laser S&T Development Co.,Ltd | 2024-02-06 | Traditional | PDF ↗ |
| K233756 | Artemis Diode Laser System (RL-S20S-TWC, RL-S20S-810B, RL-S20S-755) | Rhein Laser Technologies Co., Ltd. | 2024-02-02 | Traditional | PDF ↗ |
| K233143 | PiXel8-Reveal | Rohrer Aesthetics | 2024-02-02 | Traditional | PDF ↗ |
| K233804 | Resonic Rapid Acoustic Pulse Device | Zeltiq Aesthetics, Inc. | 2024-02-01 | Traditional | PDF ↗ |
| K231910 | DermRays Revive | Wuhan Lotuxs Technology Co., Ltd. | 2024-01-30 | Traditional | PDF ↗ |
| K233224 | Epilaser Pro | Epilady 2000, LLC | 2024-01-27 | Traditional | PDF ↗ |
| K233077 | FlashHeal 2 (FlashHeal 2.0) | Inwound Aps | 2024-01-18 | Traditional | PDF ↗ |
| K232106 | Air Gap Fiber | Wontech Co., Ltd. | 2024-01-08 | Traditional | PDF ↗ |
| K221766 | Solon | Lmg Lasers Comercio, Importacao E Exportacao Ltda | 2024-01-05 | Traditional | PDF ↗ |
| K233304 | Omnimax S3, Omnimax S4 | Sharplight Technologies, Ltd. | 2023-12-22 | Traditional | PDF ↗ |
| K233018 | PICOSECOND Nd:YAG Laser System | Ids, Ltd. | 2023-12-21 | Traditional | PDF ↗ |
| K233237 | xeo+ Family | Cutera, Inc. | 2023-12-15 | Traditional | PDF ↗ |
| K231061 | NeuroBlate System | Monteris Medical, | 2023-12-08 | Traditional | PDF ↗ |
| K232769 | BeaMed Laser Surgery Fibers | Bt Beamedical Tachnoogies Ltd. (Beamed) | 2023-12-06 | Traditional | PDF ↗ |
| K233301 | ULTRApulse Alpha CO2 Laser System, Delivery Devices and Accessories | Lumenis Be, Ltd. | 2023-12-01 | Special | PDF ↗ |
| K232709 | Diode laser therapy device | Hebei Zhemai Technology Co., Ltd. | 2023-11-30 | Traditional | PDF ↗ |
| K232716 | Q-Switched Nd:Yag laser | Hebei Zhemai Technology Co., Ltd. | 2023-11-30 | Traditional | PDF ↗ |
| K232117 | Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064) | Wuhan Lotuxs Technology Co., Ltd. | 2023-11-28 | Traditional | PDF ↗ |
| K232532 | Nd:Yag Laser Therapy Systems | Beijing Unt Technology Co., Ltd. | 2023-11-02 | Traditional | PDF ↗ |
| K233090 | DEKA AGAIN PRO family | El.En S.P.A. | 2023-10-27 | Special | PDF ↗ |
| K232236 | Echo | Quanta System Spa | 2023-10-20 | Traditional | PDF ↗ |
| K231901 | Hakon, Hakon Smart | Medical San Indústria DE Equipamentos Médicos Ltda. | 2023-09-28 | Traditional | PDF ↗ |
| K231894 | LED Spectrum therapy instrument | Shenzhenshi Sincoheren S&T Development Co., Ltd. | 2023-09-20 | Traditional | PDF ↗ |
| K231791 | PENTO Nd:YAG and Alexandrite laser system | Ilooda Co,., Ltd. | 2023-09-15 | Traditional | PDF ↗ |
| K230535 | KARL STORZ Urological Laser Accessories | Karl Storz SE & CO. KG | 2023-09-08 | Traditional | PDF ↗ |
| K223727 | Lavieen | Wontech Co., Ltd. | 2023-08-25 | Traditional | PDF ↗ |
| K231718 | Holmium Medical Laser | Allengers Global Healthcare Private Limited | 2023-08-18 | Traditional | PDF ↗ |
| K230342 | Phototherapy System (OL-PDT950) | Shanghai Omni Laser Skinology Co., Ltd. | 2023-08-16 | Traditional | PDF ↗ |
| K231054 | V-Laser | Wontech Co., Ltd. | 2023-08-14 | Special | PDF ↗ |
| K230268 | ZenPro 40 | BLUECORE COMPANY Co., Ltd. | 2023-08-10 | Traditional | PDF ↗ |
| K231548 | Medical Diode Laser, Model S1Pro | Wuhan Pioon Technology Co., Ltd. | 2023-08-03 | Traditional | PDF ↗ |
| K222862 | SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWC | Lotuxs Medtech (Suzhou) Co., Ltd. | 2023-07-30 | Traditional | PDF ↗ |
| K231945 | VenaCure EVLT NeverTouch Procedure Kits; VenaCure EVLT NeverTouch Direct Procedure Kits | AngioDynamics, Inc. | 2023-07-20 | Special | PDF ↗ |
| K230077 | LaserME | Neauvia North America | 2023-07-17 | Traditional | PDF ↗ |
| K212734 | Diode laser therapy device | Triangel Rsd Limited | 2023-06-06 | Traditional | PDF ↗ |
| K230660 | AviClear Laser System | Cutera, Inc. | 2023-06-06 | Traditional | PDF ↗ |
| K212733 | Diode laser therapy device | Beijing Star New Tech Co., Ltd. | 2023-06-06 | Traditional | PDF ↗ |
| K231309 | SCAR 3 | El.En Electroinc Engineering Spa | 2023-06-02 | Special | PDF ↗ |
| K230990 | Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta) | Candela Corporation | 2023-06-01 | Traditional | PDF ↗ |
| K230580 | Diode Laser System | Smedtrum Medical Technology Co., Ltd. | 2023-05-26 | Traditional | PDF ↗ |
| K230373 | HELIOS 785 Pico | Laseroptek Co., Ltd. | 2023-05-22 | Traditional | PDF ↗ |
| K230460 | Laser Thermal Therapy Kit | Elesta S.P.A | 2023-05-22 | Traditional | PDF ↗ |
| K230340 | Lucas Plus | Amt Engineering Co., Ltd. | 2023-05-04 | Traditional | PDF ↗ |
| K222352 | Epildream HP 4000 MED | D.E.A Project S.R.1. | 2023-04-27 | Traditional | PDF ↗ |
| K230819 | OmniGuide RFID Surgical Laser Fibers | Omni-Guide Holdings, Inc. | 2023-04-21 | Special | PDF ↗ |
| K230274 | Medical Diode Laser (M2) | Wuhan Pioon Technology Co., Ltd. | 2023-03-31 | Traditional | PDF ↗ |
| K223778 | Diode Laser Hair Removal System (RD-SLD600) | Shanghai Omni Laser Skinology Co., Ltd. | 2023-03-31 | Traditional | PDF ↗ |
| K222485 | SMARTRION COMBI/Alexandrite & Long Pulsed Nd:YAG Laser | Ids, Limited | 2023-03-29 | Traditional | PDF ↗ |
| K222983 | NeuroBlate Fusion-S Software V3.17 | Monteris Medical, | 2023-03-15 | Traditional | PDF ↗ |
| K221623 | FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nm | Gme German Medical Engineering GmbH | 2023-03-10 | Traditional | PDF ↗ |
| K230308 | Alma Harmony | Alma Lasers, Inc. | 2023-03-01 | Traditional | PDF ↗ |
| K230371 | The Alma Soprano Titanium | Alma Lasers, Inc. | 2023-02-22 | Special | PDF ↗ |
| K213669 | LIGHTSCALPEL LS-4020 | Lightscalpel, Inc. | 2023-02-15 | Traditional | PDF ↗ |
| K223680 | Eneka Pro | Termosalud | 2023-02-10 | Traditional | PDF ↗ |
| K222751 | LED Light Therapy Device, KN-7000L | Xuzhou Kernel Medical Equipment Co., Ltd. | 2023-02-01 | Traditional | PDF ↗ |
| K221306 | SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and Accessories | Gyrus Acmi, Inc. | 2023-01-27 | Traditional | PDF ↗ |
| K223588 | PALLAS Premium | Laseroptek Co., Ltd. | 2023-01-26 | Traditional | PDF ↗ |
| K223404 | Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4V | Quanta System Spa | 2023-01-20 | Special | PDF ↗ |
| K223540 | AvalancheLase Family | Fotona D.O.O. | 2023-01-19 | Traditional | PDF ↗ |
| K222221 | DEKA HELIX | El.En Electronic Engineering Spa | 2023-01-04 | Traditional | PDF ↗ |
| K223685 | SmoothCool HR System | Jeisys Medical, Inc. | 2023-01-04 | Special | PDF ↗ |
| K223647 | CLEAR+BRILLIANT TOUCH® Laser System | Solta Medical, Inc. | 2022-12-29 | Traditional | PDF ↗ |
| K213105 | Epilaser Absolute | Epilady 2000, LLC | 2022-12-13 | Traditional | PDF ↗ |
| K222916 | US 450 Diode Laser Equipment | Beijing Globalipl Development Co., Ltd. | 2022-12-09 | Traditional | PDF ↗ |
| K222701 | MANTA Laser | Squalus Med , Ltd. | 2022-11-18 | Traditional | PDF ↗ |
| K222673 | Alexandrite and Nd:YAG Laser models CANLASE and TORLASE | Canadian Pioneer Medical Technology Corporation (Cpmt Laser) | 2022-11-17 | Traditional | PDF ↗ |
| K222109 | Accure Laser | Accure Acne, Inc. | 2022-11-17 | Traditional | PDF ↗ |
| K222915 | Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE PLUS | Canadian Pioneer Medical Technology Corporation (Cpmt Laser) | 2022-11-15 | Traditional | PDF ↗ |
| K222800 | Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A) | Sanhe Laserconn Tech Co., Ltd. | 2022-11-07 | Traditional | PDF ↗ |
| K220853 | PicoWay Laser System | Candela Corporation | 2022-10-13 | Traditional | PDF ↗ |
| K221712 | Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm) | Fotona D.O.O. | 2022-10-12 | Traditional | PDF ↗ |
| K222064 | The Alma Soprano Titanium | Alma Lasers, Inc. | 2022-10-12 | Traditional | PDF ↗ |
| K222369 | PURE Laser | Endymed Medical, Ltd. | 2022-10-07 | Traditional | PDF ↗ |
| K202953 | Aurolase Therapy, Laser Delivery Device (LDD) | Nanospectra Biosciences, Inc. | 2022-10-03 | Traditional | PDF ↗ |
| K222629 | Resonic Rapid Acoustic Pulse Device | Zeltiq Aesthetics, Inc. | 2022-09-25 | Traditional | PDF ↗ |
| K222555 | reepot Nd; YAG laser system | Ilooda Co,., Ltd. | 2022-09-23 | Traditional | PDF ↗ |
| K211605 | Dual Switch | Laser Engineering, Inc. | 2022-09-22 | Special | PDF ↗ |
| K221597 | CO2 Laser System | Smedtrum Medical Technology Co., Ltd. | 2022-09-15 | Traditional | PDF ↗ |
| K213267 | Dynamis Pro Family | Fotona D.O.O. | 2022-09-08 | Traditional | PDF ↗ |
| K220531 | FOX 810, FOX 980 | A.R.C Laser GmbH | 2022-09-01 | Traditional | PDF ↗ |
| K221427 | V-Laser | Wontech Co., Ltd. | 2022-08-24 | Special | PDF ↗ |
| K220268 | Picosecond Laser System (Model PS10-A and PS10-B) | Beijing Adss Development Co., Ltd. | 2022-08-23 | Traditional | PDF ↗ |
| K212790 | XLase Plus | Biotec Italia, Srl | 2022-08-15 | Traditional | PDF ↗ |
| K221789 | IRIS Pi Q switched Nd YAG laser | Bio-Med USA, Inc. | 2022-08-09 | Traditional | PDF ↗ |
| K213252 | Dornier Thulio | Dornier Medtech America, Inc. | 2022-07-27 | Traditional | PDF ↗ |
| K213761 | Joule diVa System | Sciton, Inc | 2022-07-19 | Traditional | PDF ↗ |
| K212073 | Alma Diode Tabletop Laser | Alma Lasers , Ltd. | 2022-07-14 | Traditional | PDF ↗ |
| K221083 | Smartlux Mini | Medmix Co., Ltd. | 2022-07-12 | Traditional | PDF ↗ |
| K221571 | InMode Multi-system | InMode , Ltd. | 2022-06-30 | Special | PDF ↗ |
| K221312 | Diode Laser Hair Removal Device | Guangzhou Chuang Zao Mei Technology Co., Ltd. | 2022-06-29 | Traditional | PDF ↗ |
| K213726 | PL-1 Skin Treatment System | AVAVA, Inc. | 2022-06-28 | Traditional | PDF ↗ |
| K213250 | Secret Duo | Ilooda Co,., Ltd. | 2022-06-24 | Traditional | PDF ↗ |
Product code GEX · Class II · General, Plastic Surgery. Data: openFDA.