510(k) Report

Devices descending from K983215

377 later devices reach Multipulse CO2 Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K130793Newa Skin Therapy SystemEndymion Medical, Ltd.20130—
+4K130193Fraxel Dual 1550/1927 Laser SystemSolta Medical, Inc.201325—
+4K123494SOLEAConvergent Dental, Inc.201331
+4K120513Glow by EndymedEndymed Medical, Ltd.20125—
+4K120433Clear + Brilliant Laser SystemSolta Medical, Inc.20121—
+4K111831MX-7000 MicroxelBio-Med USA, Inc.20111—
+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—
+4K100415Acupulse 30/40 ST CO2 Laser System and Acupulse 40WG CO2 Laser SystemLumenis2010101
+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—
+5K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+5K251632Optimas MAX SystemInMode, Ltd.20251—
+5K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.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—
+5K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+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—
+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—
+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—
+5K192331LaseMD LEO Laser SystemLutronic Global20190—
+5K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+5K182173Joule SystemSciton, Inc20195—
+5K173827LightScalpelLightscalpel, LLC20180—
+5K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+5K173359Fractional CO2 Surgical Laser SystemAmi, Inc.20180—
+5K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+5K180508Joule SystemSciton, Inc20183—
+5K180597AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUOLumenis, Ltd.20183—
+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—
+5K172096FraxisIlooda Co,., Ltd.20172—
+5K171009LASEMD Laser SystemLutronic Corporation20178—
+5K170325Secret RFIlooda Co,., Ltd.201710—
+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—
+5K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+5K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+5K151306SoleaConvergent Dental, Inc.20151—
+5K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+5K141237Harmony LiteAlma, Inc.20154—
+5K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+5K132754Neogen PSR SystemEnergist, Ltd.20132—
+5K130420SOLEAConvergent Dental, Inc.201321
+5K121977Plasmajet Neutral Plasma Surgery SystemPlasma Surgical Limited20121—
+5K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+5K110897Cortex CO2 / ER:Yag Laser SystemSandstone Medical Technologies, LLC20112—
+5K110907Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc.201157—
+5K103664Primus Aesthetic PlatformPalomar Medical Technologies, Inc.20117—
+6K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+6K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+6K260974CO2 Laser Machine (Monica-I,Monica-II)Nanjing Bestview Laser S&T Co., Ltd.20260—
+6K253917ARION ARC SystemPlasma Surgical, Inc.20260—
+6K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+6K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+6K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+6K250782Fractional CO2 Laser MachineZhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+6K250465CO2 Laser Machine (Lume)Nanjing Bestview Laser S&T Co., Ltd.20250—
+6K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.20251—
+6K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+6K243139Reverso Pro SystemIndiba S. A. U.20250—