510(k) submissions
All indexed GEX clearances · showing 651–668 of 668
| K number | Device name | Company | Technology | Class | Decision |
|---|---|---|---|---|---|
| K150516 | DEKA SYNCHRO REPLA:Y FAMILY OF LASER SYSTEMSHair removal | El.En Electronic Engineering SpaItaly | Alexandrite | Class 2 | 2015-04-13 |
| K143723 | SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroSurgical cutting | Fotona D.D.Slovenia | Er:YAG | Class 2 | 2015-04-09 |
| K150027 | CYMASurgical cutting | Whitecap Technologies, LLCUnited States | CO2 | Class 2 | 2015-04-03 |
| K133788 | COOK HOLMIUM LASER FIBERSurgical cutting | Cook IncorporatedUnited States | Other | Class 2 | 2015-03-18 |
| K143519 | The MeDioStar NeXT FamilyVascular treatment | Asclepion Laser Technologies GmbHUnited States | Diode | Class 2 | 2015-03-10 |
| K141975 | WATERLASE IPLUS SSurgical cutting | Biolase, Inc.United States | Other | Class 2 | 2015-03-05 |
| K150336 | Photonica ProfessionalVascular treatment | Ward Photonics, LLCUnited States | Other | Class 2 | 2015-02-24 |
| K143105 | Picosure WorkstationPigment treatment | Cynosure, LLCUnited States | Picosecond | Class 2 | 2015-02-23 |
| K143457 | NeuroBlate SystemSurgical cutting | Monteris Medical,United States | Other | Class 2 | 2015-02-19 |
| K142924 | Shaser Skin Beauty SkinREJUV Intense, Pulsed Light System FamilyPigment treatment | Shaser, Inc.United States | Other | Class 2 | 2015-02-13 |
| K141986 | ELUX 810 LASERHair removal | Equipmed North America, Inc.United States | Diode | Class 2 | 2015-01-30 |
| K133891 | MULTIPULSE TM+1470Surgical cutting | Asclepion Laser Technologies GmbHUnited States | Other | Class 2 | 2015-01-30 |
| K141511 | SIDELAZE800 LASER BEAM DELIVERY ACCESSORY FOR CYNOSURE 1440MM WAVELENGTH LASERSSurgical cutting | Cynosure, LLCUnited States | Other | Class 2 | 2015-01-23 |
| K142860 | Lumenis M22 SystemPigment treatment | Lumenis, Inc.United States | Other | Class 2 | 2015-01-21 |
| K142952 | InMode Diolaze DeviceHair removal | Inmode MD , Ltd.Israel | Diode | Class 2 | 2015-01-13 |
| K141852 | IFS ADVANCED FEMTOSECOND LASER SYSTEMSurgical cutting | Amo Manufacturing USA, LLCUnited States | Other | Class 2 | 2015-01-06 |
| K143154 | IRIDEX CycloG6 Laser System, MicroPulse P3 Drive, G-Probe(RFID)Surgical cutting | Iridex CorporationUnited States | Other | Class 2 | 2015-01-02 |
| K141851 | NAVILAS LASER SYSTEMVascular treatment | Od-Os GmbHUnited States | Other | Class 2 | 2015-01-02 |