510(k) submissions
All indexed GEX clearances · showing 601–650 of 667
| K number | Device name | Company | Technology | Class | Decision |
|---|---|---|---|---|---|
| K160480 | PicoSure WorkstationPigment treatment | Cynosure, LLCUnited States | Picosecond | Class 2 | 2016-05-17 |
| K160952 | Alma Diode Tabletop LaserVascular treatment | Alma, Ltd.United States | Diode | Class 2 | 2016-05-05 |
| K160227 | ACCENTO / HWA Dual/Single laserHair removal | Bison Medical Co, Ltd.Korea, Republic of | Alexandrite | Class 2 | 2016-04-22 |
| 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 |
| K153229 | SuperbiumVascular treatment | Bios S.R.L.Italy | Nd:YAG | Class 2 | 2016-04-12 |
| 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 |
| K153564 | PURE CRYOGENHair removal | Air Liquide Healthcare America CorporationUnited States | Other | Class 2 | 2016-03-29 |
| 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 |
| K153671 | Family of CoolGlide Aesthetic LasersHair removal | Cutera, Inc.United States | Alexandrite | Class 2 | 2016-03-09 |
| K153527 | PicoWay Laser SystemPigment treatment | Syneron-CandelaUnited States | Picosecond | Class 2 | 2016-03-02 |
| K160392 | Novilase Laser Therapy System, Model LTS-2Surgical cutting | Novian Health, Inc.United States | Other | Class 2 | 2016-02-26 |
| K152736 | SKIN CAREHair removal | C.I.S, Ltd.Israel | Other | Class 2 | 2016-02-25 |
| K152611 | V20 systemAcne treatment | Viora , Ltd.Israel | Other | Class 2 | 2016-02-19 |
| K153718 | Spirit Hair Removal laser FamilyHair removal | Active Optical Systems , Ltd.United States | Diode | Class 2 | 2016-02-12 |
| K151569 | Tranberg CLS Laser FiberSurgical cutting | Clinical Laserthermia Systems, ABSweden | Other | Class 2 | 2016-02-12 |
| K152898 | DIODE LASER THERAPY SYSTEMSHair removal | Beijing Sincoheren Science and Tech. Development Co., Ltd.China | Diode | Class 2 | 2016-02-09 |
| K152529 | NaturaLase CO2 Laser SystemSurgical cutting | Focus Medical, LLCUnited States | CO2 | Class 2 | 2016-02-04 |
| K143713 | Lustre PRO Light SystemAcne treatment | Ambicare Health, Ltd.United Kingdom | Other | Class 2 | 2016-01-19 |
| 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 |
| K152714 | Quanta ForteHair removal | Quanta System SpaItaly | Diode | Class 2 | 2015-12-21 |
| K152636 | Laser DockSurgical cutting | Patient Pocket, LLCUnited States | Other | Class 2 | 2015-12-17 |
| K152153 | MicroSpot HandpieceSkin resurfacing | Asclepion Laser Technologies GmbHUnited States | Er:YAG | Class 2 | 2015-12-11 |
| 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 |
| K151109 | Lumenis Smart532 Laser SystemVascular treatment | Lumenis, Inc.United States | Other | Class 2 | 2015-10-30 |
| K151629 | Guardian 1000Vascular treatment | Quanta System SpaItaly | Other | Class 2 | 2015-10-27 |
| 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 |
| K151473 | NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and Pulse Slicing ModulePigment treatment | Focus Medical, LLCUnited States | Q-Switched | Class 2 | 2015-09-01 |
| K151947 | LightSheer Desire Light Laser SystemHair removal | Lumenis, Inc.Israel | Diode | Class 2 | 2015-08-12 |
| K151232 | VIKINI Diode Laser SystemHair removal | Ilooda Co,., Ltd.Korea, Republic of | Diode | Class 2 | 2015-08-06 |
| K150587 | Cortex Laser SystemSurgical cutting | Cynosure, Inc. Dba EllmanUnited States | CO2 | Class 2 | 2015-07-21 |
| K150907 | Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys UltraHair removal | Ellipse A/SDenmark | Other | Class 2 | 2015-07-07 |
| 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 |
| K140386 | LUMINA 24Pigment treatment | Rogers Sciences, Inc.United States | Other | Class 2 | 2015-05-26 |
| K143666 | Noblex Long Pulse Alexandrite LaserHair removal | Finemec Co., Ltd.Korea, Republic of | Alexandrite | Class 2 | 2015-04-23 |
| K142216 | Tranberg CLS Thermal Therapy SystemSurgical cutting | Clinical Laserthermia Systems, ABSweden | Diode | Class 2 | 2015-04-21 |
| K142186 | DIODE LASER HAIR REMOVAL SYSTEMHair removal | Shenzhen Gsd Tech Co., Ltd.China | Diode | Class 2 | 2015-04-17 |
| K150326 | PicoWay Laser SystemPigment treatment | Candela CorporationUnited States | Picosecond | Class 2 | 2015-04-16 |
| K150516 | DEKA SYNCHRO REPLA:Y FAMILY OF LASER SYSTEMSHair removal | El.En Electronic Engineering SpaItaly | Alexandrite | Class 2 | 2015-04-13 |