510(k) Report

Devices descending from K936109

678 later devices reach Sharplan Model 1120 CO2 Surgical Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K170325Secret RFIlooda Co,., Ltd.201710—
+5K161925CO2 Laser Therapy MachineBeijing Adss Development Co., Ltd.201614—
+5K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+5K160075Accent XLAlma Lasers, Inc.20160—
+5K153229SuperbiumBios S.R.L.20162—
+5K151655CO2RE SystemSyneron Medical, Ltd.20151—
+5K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+5K150161Venus Viva SR DeviceVenus Concept, Ltd.20159—
+5K141868Tria FanpTria Beauty, Inc.20140—
+5K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+5K141658Light ScalpelLightscalpel, LLC20142—
+5K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+5K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+5K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+5K132976AdvatxAdvalight Aps20141—
+5K130501IntensifEndymed Medical, Ltd.201457—
+5K132661LightscalpelLightscalpel, LLC20143—
+5K131758Surgen UPollogen, Ltd.20135—
+5K132754Neogen PSR SystemEnergist, Ltd.20132—
+5K130793Newa Skin Therapy SystemEndymion Medical, Ltd.20130—
+5K130193Fraxel Dual 1550/1927 Laser SystemSolta Medical, Inc.201325—
+5K123494SOLEAConvergent Dental, Inc.201331
+5K120513Glow by EndymedEndymed Medical, Ltd.20125—
+5K120433Clear + Brilliant Laser SystemSolta Medical, Inc.20121—
+5K111831MX-7000 MicroxelBio-Med USA, Inc.20111—
+5K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+5K110672Etwo Skin Treatment SystemSyneron, Ltd.20112—
+5K110349Clear+Brilliant Laser SystemSolta Medical, Inc.20116—
+5K101506LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc.2010156—
+5K100415Acupulse 30/40 ST CO2 Laser System and Acupulse 40WG CO2 Laser SystemLumenis2010101
+5K100270Artisan Aesthetic SystemPalomar Medical Technologies, Inc.2010157—
+5K093793LS-40 CO2 Laser System Model LS-40Sandstone Medical Technologies, LLC20103—
+5K082101LS Family of CO2 Lasers with Scanning HandpieceSandstone Medical Technologies, LLC20080—
+5K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+5K073583Modification to Palomar LUX1540 HandpiecePalomar Medical Products, Inc.2008159—
+5K050412VapormaxTrimedyne, Inc.20052—
+5K022338Optical Integrity General Shaped FiberOptical Integrity, Inc.20021—
+5K020673Wave Form Manufacturing Prolase General Shaped FiberWave Form Mfg., Inc.20022—
+5K012519Arthrocare Electrosurgery WandsArthrocare Corp.20013—
+5K011703Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength (HO:Yag/ND:Yag)…Lumenis20013422
+6K252561BTL-754FFBTL Industries, Inc.20260—
+6K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+6K252519CO2 Laser Therapy System (K106)Hebei Keylaser Sci-Tech Co.,Ltd20250—
+6K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+6K251632Optimas MAX SystemInMode, Ltd.20251—
+6K250782Fractional CO2 Laser MachineZhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+6K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+6K250183CO2 Laser System (CO2 Laser SST-L23)Zhuozhou Summer Star Technologies Co., Ltd.20250—
+6K250189AdvaTxAdvalight Aps20250—
+6K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+6K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+6K242941CO2 Laser Therapy Systems (SHE-LSP003-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+6K242183Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd.20240—
+6K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+6K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+6K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+6K233024Alma HarmonyAlma Lasers, Inc.20241—
+6K230077LaserMENeauvia North America20232—
+6K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+6K231309SCAR 3El.En Electroinc Engineering Spa20230—
+6K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+6K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+6K222685NIRA Model 2Dermal Photonics Corp20230—
+6K221873NeoGen PSR SystemEnergist Limited20230—
+6K222221Deka HelixEl.En Electronic Engineering Spa20231—
+6K223647CLEAR+BRILLIANT TOUCH® Laser SystemSolta Medical, Inc.20220—
+6K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+6K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+6K213332Multifrax Laser SystemParadigm Medical Corporation20220—
+6K210084SilkroHironic Co., Ltd.20223—
+6K211652Renuvion Dermal Handpiece, Renuvion Dermal SystemApyx Medical Corporation (Formerly Bovie Medical Corporation20220—
+6K220467The Family of UltraPulse CO2 Surgical and Aesthetic Lasers, Delivery Devices and…Lumenis Be, Ltd.20220—
+6K210183Waterlase iPLusBiolase, Inc.20220—
+6K212492Frax 1940 for Nordlys and Frax ProCandela Corporation20210—
+6K211444CellFX SystemPulse Biosciences, Inc.20213—
+6K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+6K202988Tixel SystemNovoxel, Ltd.20211—
+6K193201BTL-785FBtl20208—
+6K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.20205—
+6K201164Venus Viva MD DeviceVenus Concept USA, Inc.20203—
+6K192856MT OneM&T S.R.L.20202—
+6K191065Venus VivaTMVenus Concept USA, Inc.20200—
+6K192951Ellipse Frax 1940 for Ellipse Nordlys and Ellipse YdunEllipse A/S20201—
+6K193367elysion-proHigh Technology Products S.L.U20203—
+6K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+6K192528CO2 Laser Therapy SystemShangdong Huamei Technology Co., Ltd.20198—
+6K192331LaseMD LEO Laser SystemLutronic Global20190—
+6K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+6K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+6K182173Joule SystemSciton, Inc20195—
+6K173827LightScalpelLightscalpel, LLC20180—
+6K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+6K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+6K173359Fractional CO2 Surgical Laser SystemAmi, Inc.20180—
+6K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+6K180508Joule SystemSciton, Inc20183—
+6K180597AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUOLumenis, Ltd.20183—
+6K180406Ellipse YdunEllipse A/S20180—
+6K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+6K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—