510(k) Report

Devices descending from K091115

27 later devices reach ECO2 Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133915Galaxy CO2 Laser SystemBeijing Toplaser Technology Co., Ltd.20142—
+1K123573Youlaser CO2 LaserQuanta System Spa201319—
+1K100610Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser SystemsLutronic Corporation20113—
+2K244060eCO2 3DLutronic Corporation20250—
+2K182669Youlaser CO2Quanta System Spa20181—
+2K160312Fraxis DuoIlooda Co,., Ltd.201614—
+2K152529NaturaLase CO2 Laser SystemFocus Medical, LLC20160—
+2K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+2K150027CYMAWhitecap Technologies, LLC20150—
+2K111831MX-7000 MicroxelBio-Med USA, Inc.20111—
+3K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+3K173359Fractional CO2 Surgical Laser SystemAmi, Inc.20180—
+3K172096FraxisIlooda Co,., Ltd.20172—
+3K170325Secret RFIlooda Co,., Ltd.201710—
+3K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+4K250782Fractional CO2 Laser MachineZhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+4K242183Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd.20240—
+4K210084SilkroHironic Co., Ltd.20223—
+4K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+4K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+5K233123SilkroHironic Co., Ltd.20241—
+5K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—
+5K233099GladiatorRohrer Aesthetics, LLC20240—
+5K233143PiXel8-RevealRohrer Aesthetics20240—
+5K233147PiXel8-RFRohrer Aesthetics20230—
+5K211000AcutronIlooda Co,., Ltd.20220—
+6K251334New Doublo 2.0Hironic Co., Ltd.20250—