510(k) Report

Devices descending from K963229

397 later devices reach Sharplan Models 20C, 30C, and 40C CO2 Lasers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+4K173827LightScalpelLightscalpel, LLC20180—
+4K173359Fractional CO2 Surgical Laser SystemAmi, Inc.20180—
+4K180993Beacon Advanced CO2 Laser SystemOmniguide, Inc.20180—
+4K173285Joule SystemSciton, Inc20185—
+4K172096FraxisIlooda Co,., Ltd.20172—
+4K163137NIRA Beauty Skin LaserDermal Photonics Corporation20171—
+4K170325Secret RFIlooda Co,., Ltd.201710—
+4K161925CO2 Laser Therapy MachineBeijing Adss Development Co., Ltd.201614—
+4K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+4K160075Accent XLAlma Lasers, Inc.20160—
+4K153229SuperbiumBios S.R.L.20162—
+4K151655CO2RE SystemSyneron Medical, Ltd.20151—
+4K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+4K150161Venus Viva SR DeviceVenus Concept, Ltd.20159—
+4K141868Tria FanpTria Beauty, Inc.20140—
+4K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+4K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+4K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+4K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+4K132976AdvatxAdvalight Aps20141—
+4K130501IntensifEndymed Medical, Ltd.201457—
+4K131758Surgen UPollogen, Ltd.20135—
+4K130793Newa Skin Therapy SystemEndymion Medical, Ltd.20130—
+4K130193Fraxel Dual 1550/1927 Laser SystemSolta Medical, Inc.201325—
+4K120513Glow by EndymedEndymed Medical, Ltd.20125—
+4K120433Clear + Brilliant Laser SystemSolta Medical, Inc.20121—
+4K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+4K110672Etwo Skin Treatment SystemSyneron, Ltd.20112—
+4K110349Clear+Brilliant Laser SystemSolta Medical, Inc.20116—
+4K101506LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc.2010156—
+4K100270Artisan Aesthetic SystemPalomar Medical Technologies, Inc.2010157—
+4K093793LS-40 CO2 Laser System Model LS-40Sandstone Medical Technologies, LLC20103—
+4K082101LS Family of CO2 Lasers with Scanning HandpieceSandstone Medical Technologies, LLC20080—
+4K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+4K082197Rhytec, Inc., Portrait PSRRhytec Incorporated20083—
+4K073583Modification to Palomar LUX1540 HandpiecePalomar Medical Products, Inc.2008159—
+5K252561BTL-754FFBTL Industries, Inc.20260—
+5K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+5K252519CO2 Laser Therapy System (K106)Hebei Keylaser Sci-Tech Co.,Ltd20250—
+5K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+5K251632Optimas MAX SystemInMode, Ltd.20251—
+5K250782Fractional CO2 Laser MachineZhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+5K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+5K250183CO2 Laser System (CO2 Laser SST-L23)Zhuozhou Summer Star Technologies Co., Ltd.20250—
+5K250189AdvaTxAdvalight Aps20250—
+5K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+5K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+5K242941CO2 Laser Therapy Systems (SHE-LSP003-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+5K242183Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd.20240—
+5K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+5K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+5K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+5K233024Alma HarmonyAlma Lasers, Inc.20241—
+5K230077LaserMENeauvia North America20232—
+5K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+5K231309SCAR 3El.En Electroinc Engineering Spa20230—
+5K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+5K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+5K222685NIRA Model 2Dermal Photonics Corp20230—
+5K222221Deka HelixEl.En Electronic Engineering Spa20231—
+5K223647CLEAR+BRILLIANT TOUCH® Laser SystemSolta Medical, Inc.20220—
+5K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+5K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+5K213332Multifrax Laser SystemParadigm Medical Corporation20220—
+5K210084SilkroHironic Co., Ltd.20223—
+5K220467The Family of UltraPulse CO2 Surgical and Aesthetic Lasers, Delivery Devices and…Lumenis Be, Ltd.20220—
+5K210183Waterlase iPLusBiolase, Inc.20220—
+5K212492Frax 1940 for Nordlys and Frax ProCandela Corporation20210—
+5K211444CellFX SystemPulse Biosciences, Inc.20213—
+5K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+5K202988Tixel SystemNovoxel, Ltd.20211—
+5K202428AcuPulse W CO2 Laser Systems, Delivery Devices and AccessoriesLumenis, Ltd.20201—
+5K193201BTL-785FBtl20208—
+5K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.20205—
+5K201164Venus Viva MD DeviceVenus Concept USA, Inc.20203—
+5K192856MT OneM&T S.R.L.20202—
+5K191065Venus VivaTMVenus Concept USA, Inc.20200—
+5K192951Ellipse Frax 1940 for Ellipse Nordlys and Ellipse YdunEllipse A/S20201—
+5K193367elysion-proHigh Technology Products S.L.U20203—
+5K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+5K192528CO2 Laser Therapy SystemShangdong Huamei Technology Co., Ltd.20198—
+5K192331LaseMD LEO Laser SystemLutronic Global20190—
+5K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+5K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+5K182173Joule SystemSciton, Inc20195—
+5K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+5K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+5K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+5K180508Joule SystemSciton, Inc20183—
+5K180406Ellipse YdunEllipse A/S20180—
+5K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+5K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+5K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+5K162398CO2 Laser Therapy SystemsBeijing Sincoheren Science and Technology Development Co.20172—
+5K171009LASEMD Laser SystemLutronic Corporation20178—
+5K163196ACTION II Laser SystemLutronic Corporation20170—
+5K162169EdgeOne CO2 LaserJeisys Medical, Inc.20167—
+5K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+5K153717Venus Versa SystemVenus Concept, Ltd.20161—