510(k) submissions
Filtered by Surgical cutting · showing 201–250 of 340
| K number | Device name | Company | Technology | Class | Decision |
|---|---|---|---|---|---|
| K191842 | Discovery Pico, Discovery Pico Plus, Discovery Pico DermPigment treatment | Quanta System SpaItaly | Q-Switched | Class 2 | 2019-09-17 |
| K191518 | CO2 Laser SystemSkin resurfacing | Shenzhen Gsd Tech Co., Ltd.China | CO2 | Class 2 | 2019-09-12 |
| K181614 | Sterling Supreme Diode LaserSurgical cutting | CAO Group, Inc.United States | Diode | Class 2 | 2019-09-10 |
| K181602 | Pioneer Elite Diode LaserSurgical cutting | CAO Group, Inc.United States | Diode | Class 2 | 2019-09-10 |
| K181601 | Precise SHP Diode LaserSurgical cutting | CAO Group, Inc.United States | Diode | Class 2 | 2019-09-09 |
| K183563 | Holinwon 30Surgical cutting | Wontech Co., Ltd.Korea, Republic of | CO2 | Class 2 | 2019-09-05 |
| K191554 | LightWalker Laser System FamilySurgical cutting | Fotona D.O.O.Slovenia | Er:YAG | Class 2 | 2019-08-30 |
| K191349 | 980nm Diode Laser Therapy DeviceSurgical cutting | Shanghai Apolo Medical Technology Co., Ltd.China | Diode | Class 2 | 2019-08-16 |
| K183647 | SOLTIVE™ Laser System(SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™Laser Fibers, and Accessories)Surgical cutting | Olympus Surgical Technologies AmericaUnited States | Thulium fiber | Class 2 | 2019-08-09 |
| K182930 | PerioLase Nd:YAG Pulsed Dental Laser SystemSurgical cutting | Millennium Dental Technologies, Inc.United States | Nd:YAG | Class 2 | 2019-07-12 |
| K190936 | Q-Switched Nd: YAG Laser SystemPigment treatment | Shanghai Apolo Medical Technology Co., Ltd.China | Nd:YAG | Class 2 | 2019-06-17 |
| K183199 | TRIO HandpieceSurgical cutting | Omniguide, Inc.United States | CO2 | Class 2 | 2019-05-02 |
| K183156 | V-LaserSurgical cutting | Wontech Co., Ltd.Korea, Republic of | Nd:YAG | Class 2 | 2019-04-24 |
| K190392 | WaveLight FS200 Patient InterfaceSurgical cutting | Alcon Laboratories, Inc.United States | Other | Class 2 | 2019-03-26 |
| K183392 | PicoLO Nd:YAG Picosecond Laser SystemPigment treatment | Laseroptek Co., Ltd.Korea, Republic of | Nd:YAG | Class 2 | 2019-01-04 |
| K182045 | Lotus III Multi-Pulsed Er: Yag Laser SystemSurgical cutting | Laseroptek Co., Ltd.Korea, Republic of | Er:YAG | Class 2 | 2018-12-27 |
| K182997 | enlighten III Laser SystemPigment treatment | Cutera, Inc.United States | Nd:YAG | Class 2 | 2018-12-12 |
| K182831 | SabreLine and SabreGuard Laser FibersSurgical cutting | Coloplast Corp.United States | Other | Class 2 | 2018-12-10 |
| K182270 | Cellene CO2 Laser SystemSurgical cutting | Bio-Med USA, Inc.United States | CO2 | Class 2 | 2018-11-02 |
| K182088 | XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroSurgical cutting | Fotona D.O.O.Slovenia | Er:YAG | Class 2 | 2018-10-31 |
| K182669 | Youlaser CO2Surgical cutting | Quanta System SpaItaly | CO2 | Class 2 | 2018-10-17 |
| K182036 | NeuroBlate SystemSurgical cutting | Monteris Medical,United States | Nd:YAG | Class 2 | 2018-10-15 |
| K181867 | Deka Smartxide2 TrioSurgical cutting | El.En Electronic Engineering SpaItaly | CO2 | Class 2 | 2018-10-02 |
| K173827 | LightScalpelSurgical cutting | Lightscalpel, Inc.United States | CO2 | Class 2 | 2018-09-14 |
| K181662 | Iridex TruFocus LIO PremiereSurgical cutting | Iridex CorporationUnited States | Other | Class 2 | 2018-09-05 |
| K181510 | ECHOLASER X4Surgical cutting | El.En Electronic Engineering SpaItaly | Other | Class 2 | 2018-09-04 |
| K181480 | MMD TipSurgical cutting | Strata Skin Sciences, Inc.United States | Other | Class 2 | 2018-08-01 |
| K181431 | Laser Ureteral CatheterSurgical cutting | Cook IncorporatedUnited States | Other | Class 2 | 2018-07-30 |
| K181523 | Syneron CO2RE SystemSurgical cutting | Syneron-CandelaUnited States | CO2 | Class 2 | 2018-07-11 |
| K180967 | Dental Diode Laser SystemSurgical cutting | Lazon Medical Laser Co., Ltd.China | Diode | Class 2 | 2018-07-11 |
| K173359 | Fractional CO2 Surgical Laser SystemSkin resurfacing | Ami, Inc.Korea, Republic of | CO2 | Class 2 | 2018-07-05 |
| K180993 | Beacon Advanced CO2 Laser SystemSurgical cutting | Omniguide, Inc.United States | CO2 | Class 2 | 2018-06-28 |
| K180508 | JOULE SYSTEMSkin resurfacing | Sciton, IncUnited States | CO2 | Class 2 | 2018-05-18 |
| K180922 | Empower H100, Cyber Ho 100, Litho 100Surgical cutting | Quanta System SpaItaly | Other | Class 2 | 2018-05-08 |
| K180140 | ProFlex Laser FibersSurgical cutting | Innovaquartz, LLCUnited States | Other | Class 2 | 2018-04-20 |
| K171443 | Etherea MXSurgical cutting | Vydence Medical Industria E Comercio LtdaBrazil | Other | Class 2 | 2018-04-20 |
| K180597 | AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUOSurgical cutting | Lumenis, Inc.Israel | CO2 | Class 2 | 2018-04-03 |
| K180426 | Empower H35Surgical cutting | Quanta System SpaItaly | Other | Class 2 | 2018-03-16 |
| K180423 | Empower H65Surgical cutting | Quanta System SpaItaly | Other | Class 2 | 2018-03-15 |
| K180406 | Ellipse YdunSurgical cutting | Ellipse A/SDenmark | Other | Class 2 | 2018-03-15 |
| K180044 | SIROLaser BlueSurgical cutting | Dentsply SironaUnited States | Other | Class 2 | 2018-03-08 |
| K180350 | Dornier Medilas H Solvo 35 LaserSurgical cutting | Dornier Medtech America, Inc.United States | Other | Class 2 | 2018-03-07 |
| K172818 | LMT-3000Surgical cutting | Lameditech Co. , Ltd.Korea, Republic of | Other | Class 2 | 2018-03-07 |
| K180193 | DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto)Skin resurfacing | El.En Electronic Engineering SpaItaly | CO2 | Class 2 | 2018-02-21 |
| K180158 | Surgical Laser fibersSurgical cutting | Quanta System SpaItaly | Other | Class 2 | 2018-02-14 |
| K172439 | Siberian FitSurgical cutting | VydenceBrazil | Other | Class 2 | 2018-02-14 |
| K172193 | Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms [SopranoXL, SopranoXLi, SopranoICE and Soprano ICE Platinum] with Duo and Trio Diode Laser Modules., Soprano Duo and Trio Diode Laser ModulesHair removal | Alma Lasers, Inc.United States | Diode | Class 2 | 2018-01-09 |
| K172908 | Q-Switched Nd:YAG Laser SystemSkin resurfacing | Ami, Inc.Korea, Republic of | Q-Switched | Class 2 | 2017-12-07 |
| K173038 | CuRAS Nd:YAG LaserSurgical cutting | Ilooda Co,., Ltd.Korea, Republic of | Nd:YAG | Class 2 | 2017-12-01 |
| K172819 | LightWalker Laser System FamilySurgical cutting | Fotona D.O.O.Slovenia | Nd:YAG | Class 2 | 2017-12-01 |