510(k) submissions
Filtered by CO2 · showing 51–79 of 79
| K number | Device name | Company | Technology | Class | Decision |
|---|---|---|---|---|---|
| K200042 | CO2 Laser SystemSurgical cutting | Beijing Superlaser Technology Co., Ltd.China | CO2 | Class 2 | 2020-06-09 |
| K192528 | CO2 Laser Therapy SystemSurgical cutting | Shangdong Huamei Technology Co., Ltd.China | CO2 | Class 2 | 2019-12-03 |
| K191518 | CO2 Laser SystemSkin resurfacing | Shenzhen Gsd Tech Co., Ltd.China | CO2 | Class 2 | 2019-09-12 |
| K183563 | Holinwon 30Surgical cutting | Wontech Co., Ltd.Korea, Republic of | CO2 | Class 2 | 2019-09-05 |
| K183199 | TRIO HandpieceSurgical cutting | Omniguide, Inc.United States | CO2 | Class 2 | 2019-05-02 |
| K182270 | Cellene CO2 Laser SystemSurgical cutting | Bio-Med USA, Inc.United States | CO2 | Class 2 | 2018-11-02 |
| K182669 | Youlaser CO2Surgical cutting | Quanta System SpaItaly | CO2 | Class 2 | 2018-10-17 |
| 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 |
| K181523 | Syneron CO2RE SystemSurgical cutting | Syneron-CandelaUnited States | CO2 | 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 |
| K180597 | AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUOSurgical cutting | Lumenis, Inc.Israel | CO2 | Class 2 | 2018-04-03 |
| K180193 | DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto)Skin resurfacing | El.En Electronic Engineering SpaItaly | CO2 | Class 2 | 2018-02-21 |
| K172363 | DEKA SMARTXIDE ULTRASPEEDSurgical cutting | El.En Electronic Engineering SpaItaly | CO2 | Class 2 | 2017-11-17 |
| K172362 | DEKA SMARTXIDE TOUCHSkin resurfacing | El.En Electronic Engineering SpaItaly | CO2 | Class 2 | 2017-11-17 |
| K172096 | FraxisSkin resurfacing | Ilooda Co,., Ltd.Korea, Republic of | CO2 | Class 2 | 2017-08-09 |
| K170215 | LaserDock, HolmiumDock, CO2Dock,OmniDock, KTPDockSkin resurfacing | Patient Pocket, LLCUnited States | CO2 | Class 2 | 2017-04-19 |
| K160312 | FRAXIS DUOSkin resurfacing | Ilooda Co,., Ltd.Korea, Republic of | CO2 | Class 2 | 2016-10-28 |
| K162169 | EdgeOne CO2 LaserSurgical cutting | Jeisys Medical IncorporatedKorea, Republic of | CO2 | Class 2 | 2016-10-27 |
| K161925 | CO2 Laser Therapy MachineSurgical cutting | Beijing Adss Development Co., Ltd.China | CO2 | Class 2 | 2016-10-05 |
| K161356 | Matrix LS-40 CO2 Laser SystemSurgical cutting | Shanghai Wonderful Opto-Electrics Tech.Co.,LtdChina | CO2 | Class 2 | 2016-09-09 |
| K152529 | NaturaLase CO2 Laser SystemSurgical cutting | Focus Medical, LLCUnited States | CO2 | Class 2 | 2016-02-04 |
| K151655 | CO2RE SystemSurgical cutting | Syneron Medical, Ltd.United States | CO2 | Class 2 | 2015-09-15 |
| 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 |
| K150027 | CYMASurgical cutting | Whitecap Technologies, LLCUnited States | CO2 | Class 2 | 2015-04-03 |
