510(k) submissions
Filtered by Surgical cutting · showing 301–340 of 340
| K number | Device name | Company | Technology | Class | Decision |
|---|---|---|---|---|---|
| K161771 | Medilas H Laser FibersSurgical cutting | Dornier Medtech America, Inc.United States | Other | Class 2 | 2016-07-28 |
| K161669 | Waterlase ExpressSurgical cutting | Biolase, Inc.United States | Other | Class 2 | 2016-07-28 |
| K153124 | DuraLazeTM HoLEP Laser FiberSurgical cutting | Medkey, LLCUnited States | Other | Class 2 | 2016-07-26 |
| K152737 | Lite TouchSurgical cutting | Focus Medical, LLCUnited States | Er:YAG | Class 2 | 2016-06-29 |
| K160012 | O-pel Laser and families of probe delivery devicesSurgical cutting | Precise Light SurgicalUnited States | Other | Class 2 | 2016-06-02 |
| K152856 | Helios IIISurgical cutting | Laseroptek Co., Ltd.Korea, Republic of | Other | Class 2 | 2016-06-02 |
| K151855 | SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral Firing FiberSurgical cutting | Surgical Laser IncorporatedUnited States | Other | Class 2 | 2016-04-15 |
| K153566 | Magma SystemHair removal | Formatk Systems , Ltd.Israel | Diode | Class 2 | 2016-04-06 |
| K160368 | EVO platformVascular treatment | Quanta System SpaItaly | Q-Switched | Class 2 | 2016-04-05 |
| K160513 | Quanta System Surgical Laser fibersSurgical cutting | Quanta System SpaItaly | Other | Class 2 | 2016-03-18 |
| K151763 | PerioLase Nd:YAG Pulsed Dental Laser SystemSurgical cutting | Millennium Dental Technologies, Inc.United States | Nd:YAG | Class 2 | 2016-03-15 |
| K160392 | Novilase Laser Therapy System, Model LTS-2Surgical cutting | Novian Health, Inc.United States | Other | Class 2 | 2016-02-26 |
| K151569 | Tranberg CLS Laser FiberSurgical cutting | Clinical Laserthermia Systems, ABSweden | Other | Class 2 | 2016-02-12 |
| K152529 | NaturaLase CO2 Laser SystemSurgical cutting | Focus Medical, LLCUnited States | CO2 | Class 2 | 2016-02-04 |
| K151890 | Medical Diode Laser SystemsSurgical cutting | Wuhan Gigaa Optronics Technology Co., Ltd.China | Diode | Class 2 | 2015-12-23 |
| K150997 | RUBY STARPigment treatment | Bison Medical Co, Ltd.Korea, Republic of | Ruby | Class 2 | 2015-12-22 |
| K150664 | NeoLasSurgical cutting | Sheaumann Laser, Inc.United States | Er:YAG | Class 2 | 2015-12-22 |
| K152636 | Laser DockSurgical cutting | Patient Pocket, LLCUnited States | Other | Class 2 | 2015-12-17 |
| K152722 | neoV980 & neoV1470 Diode LasersSurgical cutting | G.N.S Neolaser , Ltd.United States | Diode | Class 2 | 2015-12-08 |
| K152012 | EVO platformVascular treatment | Quanta System SpaItaly | Q-Switched | Class 2 | 2015-12-08 |
| K152417 | Adler MicroMed Laser Surgery FibersSurgical cutting | Adler Micromed, Inc.United States | Other | Class 2 | 2015-12-01 |
| K152939 | Picasso Plus, Picasso Lite PlusSurgical cutting | Amd Group, LLCUnited States | Diode | Class 2 | 2015-11-25 |
| K152591 | Medilas H RFID Laser FibersSurgical cutting | Dornier Medtech America, Inc.United States | Other | Class 2 | 2015-10-08 |
| K151306 | SoleaSurgical cutting | Convergent Dental, Inc.United States | Other | Class 2 | 2015-09-23 |
| K152032 | ELUMI 810 + 980 Soft Tissue LaserSurgical cutting | Azena Medical, LLCUnited States | Diode | Class 2 | 2015-09-16 |
| K151655 | CO2RE SystemSurgical cutting | Syneron Medical, Ltd.United States | CO2 | Class 2 | 2015-09-15 |
| K152220 | MH01Surgical cutting | Quanta System SpaItaly | Other | Class 2 | 2015-09-03 |
| K150587 | Cortex Laser SystemSurgical cutting | Cynosure, Inc. Dba EllmanUnited States | CO2 | Class 2 | 2015-07-21 |
| K151331 | The UltraPulse system (UltraPulse and UltraPulse DUO models,members of the modified Lumenis Family of UltraPulse SurgiTouchSurgical cutting | Lumenis, Inc.Israel | CO2 | Class 2 | 2015-06-30 |
| K150140 | MCL 31 DermablateSurgical cutting | Asclepion Laser Technologies GmbHUnited States | CO2 | Class 2 | 2015-06-05 |
| K142216 | Tranberg CLS Thermal Therapy SystemSurgical cutting | Clinical Laserthermia Systems, ABSweden | Diode | Class 2 | 2015-04-21 |
| 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 |
| K141975 | WATERLASE IPLUS SSurgical cutting | Biolase, Inc.United States | Other | Class 2 | 2015-03-05 |
| K143457 | NeuroBlate SystemSurgical cutting | Monteris Medical,United States | Other | Class 2 | 2015-02-19 |
| 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 |
| 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 |