510(k) submissions
All indexed GEX clearances · showing 251–300 of 667
| K number | Device name | Company | Technology | Class | Decision |
|---|---|---|---|---|---|
| K222109 | Accure LaserAcne treatment | Accure Acne, Inc.United States | Other | Class 2 | 2022-11-17 |
| K222915 | Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE PLUSVascular treatment | Canadian Pioneer Medical Technology Corporation (Cpmt Laser)Canada | Nd:YAG | Class 2 | 2022-11-15 |
| K222800 | Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A)Hair removal | Sanhe Laserconn Tech Co., Ltd.China | Diode | Class 2 | 2022-11-07 |
| K220853 | PicoWay Laser SystemPigment treatment | Candela CorporationUnited States | Picosecond | Class 2 | 2022-10-13 |
| K222064 | The Alma Soprano TitaniumHair removal | Alma Lasers, Inc.United States | Diode | Class 2 | 2022-10-12 |
| K221712 | Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Surgical cutting | Fotona D.O.O.Slovenia | Diode | Class 2 | 2022-10-12 |
| K222369 | PURE LaserHair removal | Endymed Medical, Ltd.Israel | Diode | Class 2 | 2022-10-07 |
| K202953 | Aurolase Therapy, Laser Delivery Device (LDD)Acne treatment | Nanospectra Biosciences, Inc.United States | Diode | Class 2 | 2022-10-03 |
| K222629 | Resonic Rapid Acoustic Pulse DevicePigment treatment | Zeltiq Aesthetics, Inc.United States | Q-Switched | Class 2 | 2022-09-25 |
| K222555 | reepot Nd; YAG laser systemSurgical cutting | Ilooda Co,., Ltd.Korea, Republic of | Nd:YAG | Class 2 | 2022-09-23 |
| K211605 | Dual SwitchSurgical cutting | Laser Engineering, Inc.United States | CO2 | Class 2 | 2022-09-22 |
| K221597 | CO2 Laser SystemSurgical cutting | Smedtrum Medical Technology Co., Ltd.Taiwan | CO2 | Class 2 | 2022-09-15 |
| K213267 | Dynamis Pro FamilySurgical cutting | Fotona D.O.O.Slovenia | Er:YAG | Class 2 | 2022-09-08 |
| K220531 | FOX 810, FOX 980Surgical cutting | A.R.C Laser GmbHUnited States | Diode | Class 2 | 2022-09-01 |
| K221427 | V-LaserSurgical cutting | Wontech Co., Ltd.Korea, Republic of | Nd:YAG | Class 2 | 2022-08-24 |
| K220268 | Picosecond Laser System (Model PS10-A and PS10-B)Pigment treatment | Beijing Adss Development Co., Ltd.China | Picosecond | Class 2 | 2022-08-23 |
| K212790 | XLase PlusHair removal | Biotec Italia, SrlItaly | Diode | Class 2 | 2022-08-15 |
| K221789 | IRIS Pi Q switched Nd YAG laserSurgical cutting | Bio-Med USA, Inc.United States | Nd:YAG | Class 2 | 2022-08-09 |
| K213252 | Dornier ThulioSurgical cutting | Dornier Medtech America, Inc.United States | Thulium fiber | Class 2 | 2022-07-27 |
| K213761 | Joule diVa SystemVascular treatment | Sciton, IncUnited States | Diode | Class 2 | 2022-07-19 |
| K212073 | Alma Diode Tabletop LaserSurgical cutting | Alma Lasers, Inc.Israel | Diode | Class 2 | 2022-07-14 |
| K221083 | Smartlux MiniAcne treatment | Medmix Co., Ltd.Korea, Republic of | Other | Class 2 | 2022-07-12 |
| K221571 | InMode Multi-systemHair removal | InMode , Ltd.Israel | Diode | Class 2 | 2022-06-30 |
| K221312 | Diode Laser Hair Removal DeviceHair removal | Guangzhou Chuang Zao Mei Technology Co., Ltd.China | Diode | Class 2 | 2022-06-29 |
| K213726 | PL-1 Skin Treatment SystemPigment treatment | AVAVA, Inc.United States | Nd:YAG | Class 2 | 2022-06-28 |
| K213250 | Secret DuoSkin resurfacing | Ilooda Co,., Ltd.Korea, Republic of | Other | Class 2 | 2022-06-24 |
| K211979 | Lumenis Y&R Laser SystemSkin resurfacing | Lumenis, Inc.United States | Other | Class 2 | 2022-06-21 |
| K212663 | HELIOS IV 785Surgical cutting | Laseroptek Co., Ltd.Korea, Republic of | Nd:YAG | Class 2 | 2022-06-09 |
| K214049 | Leaseir MHR XcellHair removal | Leaseir Technologies, SluSpain | Diode | Class 2 | 2022-06-02 |
| K213261 | EpilMEVascular treatment | Neauvia North AmericaUnited States | Diode | Class 2 | 2022-06-02 |
| K220793 | InnoVoyce Laser FiberSurgical cutting | InnovoyceUnited States | Other | Class 2 | 2022-05-25 |
| K220381 | Diode Laser Therapy SystemsHair removal | Beijing Lasertell Medical Co., Ltd.China | Diode | Class 2 | 2022-05-20 |
| K211534 | RevoLix HTLSurgical cutting | Lisa Laser Products GmbHUnited States | Other | Class 2 | 2022-05-19 |
| K220467 | The Family of UltraPulse CO2 Surgical and Aesthetic Lasers, Delivery Devices and AccessoriesSurgical cutting | Lumenis Be, Ltd.Israel | CO2 | Class 2 | 2022-05-18 |
| K220041 | HandPICOAcne treatment | Vydence Medical Industria E Comercio LtdaBrazil | Other | Class 2 | 2022-05-05 |
| K213594 | ECHOLASER X4Surgical cutting | Elesta S.P.AItaly | Other | Class 2 | 2022-05-03 |
| K220189 | LISA Laser Surgical FibersSurgical cutting | Omni-Guide Holdings, Inc.United States | Other | Class 2 | 2022-04-29 |
| K213889 | PicoStarPigment treatment | Asclepion Laser Technologies GmbHUnited States | Picosecond | Class 2 | 2022-04-22 |
| K210183 | Waterlase iPLusSkin resurfacing | Biolase, Inc.United States | Other | Class 2 | 2022-04-21 |
| K213484 | SmoothCool HR SystemHair removal | Jeisys Medical IncorporatedKorea, Republic of | Other | Class 2 | 2022-04-20 |
| K213350 | mJOULE System and AccessoriesVascular treatment | Sciton, IncUnited States | Nd:YAG | Class 2 | 2022-04-15 |
| K210634 | MCL 31 Dermablate SystemSkin resurfacing | Asclepion Laser Technologies GmbHUnited States | CO2 | Class 2 | 2022-04-13 |
| K220103 | LED Therapy Device (Planar LED/Planar LED mini)Hair removal | Shenzhen Leaflife Technology Co., Ltd.China | Other | Class 2 | 2022-04-12 |
| K213557 | FinexelSurgical cutting | SNJ Co., Ltd.Korea, Republic of | CO2 | Class 2 | 2022-04-12 |
| K213461 | AviClear Laser SystemAcne treatment | Cutera, Inc.United States | Other | Class 2 | 2022-03-24 |
| K220426 | Fiber Dust PROSurgical cutting | Quanta System SpaItaly | Other | Class 2 | 2022-03-16 |
| K211722 | Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresVascular treatment | Canadian Pioneer Medical Technology CorporationCanada | Nd:YAG | Class 2 | 2022-02-25 |
| K220020 | Cryo 7Skin tightening | Zimmer Medizinsysteme GmbHUnited States | Other | Class 2 | 2022-02-04 |
| K213569 | HOLLYWOOD SPECTRA Laser SystemPigment treatment | Lutronic CorporationKorea, Republic of | Q-Switched | Class 2 | 2022-02-04 |
| K213554 | Sentient Manufacturing Laser FiberSurgical cutting | Sentient Manufacturing , LLCUnited States | Other | Class 2 | 2022-02-02 |