510(k) Report

Devices descending from K063001

63 later devices reach Slim Evolution Family of CO2 Lasers and Delivery Device Accessories through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123573Youlaser CO2 LaserQuanta System Spa201319—
+1K101555CO2 Laser SystemAdvanced Technology Laser Co., Ltd.201016—
+1K091115ECO2 Laser SystemLutronic Corporation200927—
+1K083918Atl CO2 Medical Laser Systems, Models Atl-150 and Atl-250Advanced Technology Laser Co., Ltd.20090—
+1K080463Alma Lasers Thermoxel CO2 Laser System and Delivery Device AccessoriesAlma Lasers, Ltd.200815—
+1K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+1K072023Ellipse Juvia, Model 9EJU7465Ellipse A/S20070—
+2K182669Youlaser CO2Quanta System Spa20181—
+2K160312Fraxis DuoIlooda Co,., Ltd.201614—
+2K152529NaturaLase CO2 Laser SystemFocus Medical, LLC20160—
+2K150027CYMAWhitecap Technologies, LLC20150—
+2K133915Galaxy CO2 Laser SystemBeijing Toplaser Technology Co., Ltd.20142—
+2K110434Trixel CO2 LaserBeijing Syntech Laser CO., LTD.201115—
+2K100610Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser SystemsLutronic Corporation20113—
+2K103501Alma Lasers Pixel CO2 Laser System, Delivery Device and AccessoriesAlma Lasers, Inc.201113—
+2K101321Ematrix CO2Syneron Medical, Ltd.20102—
+3K250071Alma FemiLift Pixel CO2 Laser System, Delivery Devices and AccessoriesAlma Lasers, Inc.20250—
+3K244060eCO2 3DLutronic Corporation20250—
+3K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+3K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+3K182270Cellene CO2 Laser SystemBio-Med USA, Inc.20180—
+3K172096FraxisIlooda Co,., Ltd.20172—
+3K170325Secret RFIlooda Co,., Ltd.201710—
+3K161925CO2 Laser Therapy MachineBeijing Adss Development Co., Ltd.201614—
+3K151655CO2RE SystemSyneron Medical, Ltd.20151—
+3K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+3K141658Light ScalpelLightscalpel, LLC20142—
+3K111831MX-7000 MicroxelBio-Med USA, Inc.20111—
+4K252519CO2 Laser Therapy System (K106)Hebei Keylaser Sci-Tech Co.,Ltd20250—
+4K250782Fractional CO2 Laser MachineZhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+4K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+4K250183CO2 Laser System (CO2 Laser SST-L23)Zhuozhou Summer Star Technologies Co., Ltd.20250—
+4K242941CO2 Laser Therapy Systems (SHE-LSP003-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+4K242183Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd.20240—
+4K233024Alma HarmonyAlma Lasers, Inc.20241—
+4K213669Lightscalpel LS-4020Lightscalpel, Inc.20230—
+4K222221Deka HelixEl.En Electronic Engineering Spa20231—
+4K210084SilkroHironic Co., Ltd.20223—
+4K192528CO2 Laser Therapy SystemShangdong Huamei Technology Co., Ltd.20198—
+4K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+4K173827LightScalpelLightscalpel, LLC20180—
+4K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+4K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+4K173359Fractional CO2 Surgical Laser SystemAmi, Inc.20180—
+4K162398CO2 Laser Therapy SystemsBeijing Sincoheren Science and Technology Development Co.20172—
+4K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+5K252561BTL-754FFBTL Industries, Inc.20260—
+5K233123SilkroHironic Co., Ltd.20241—
+5K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—
+5K233099GladiatorRohrer Aesthetics, LLC20240—
+5K233143PiXel8-RevealRohrer Aesthetics20240—
+5K233147PiXel8-RFRohrer Aesthetics20230—
+5K211000AcutronIlooda Co,., Ltd.20220—
+5K212611CO2 Laser EquipmentBeijing Globalipl Development Co., Ltd.20220—
+5K202250Dermatological Carbon Dioxide Laser SystemsZhuolu Jontelaser Manufacturing Technology Co., Ltd.20200—
+5K200042CO2 Laser SystemBeijing Superlaser Technology Co., Ltd.20205—
+5K191518CO2 Laser SystemShenzhen Gsd Tech Co., Ltd.20191—
+6K262269CO2 Laser System (MBT- CO2 Laser)Beijing Mega Beauty Technology Co., Ltd.20260—
+6K260257CO2 Laser SystemSanhe Meditech Co., Ltd.20260—
+6K253920CO2 Laser Treatment Machine (CFR3M1)Haidari Beauty Technology (Beijing) Co., Ltd.20260—
+6K250998CO2 Laser Therapy System (Model: LFS-D9U)Sanhe Lefis Electronics Co., Ltd.20250—
+6K251334New Doublo 2.0Hironic Co., Ltd.20250—
+6K211735CO2 Laser Machine, Model: BW-203BZhengzhou Bestview ST Co., Ltd.20210—