510(k) Report

Devices descending from K053608

199 later devices reach Cynosure Photogenica V-Star Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198—
+2K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+2K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—
+2K102954Cutera Qswitch Laser SystemCutera, Inc.201149—
+2K101916Joule Multi-Platform SystemSciton, Inc2011111—
+2K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc.2010921
+3K250165PastelleWontech Co., Ltd.20250—
+3K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+3K213761Joule diVa SystemSciton, Inc20220—
+3K202288FinebeamSNJ Co., Ltd.20212—
+3K193656SkyPulseFotona D.O.O.202011—
+3K173285Joule SystemSciton, Inc20185—
+3K140727Cutera Picosecond Laser SystemCutera, Inc.201447—
+3K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+3K133945Cutera Picosecond Laser SystemCutera, Inc.201414—
+3K133364Picosure WorkstationCynosure, Inc.201451—
+3K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+3K132976AdvatxAdvalight Aps20141—
+3K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+3K121346Picosure WorkstationCynosure, Inc.201287—
+4K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+4K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+4K250189AdvaTxAdvalight Aps20250—
+4K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+4K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+4K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+4K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+4K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+4K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+4K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+4K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+4K210183Waterlase iPLusBiolase, Inc.20220—
+4K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+4K193266MIINMedico USA, Inc.20210—
+4K201406PicowonWontech Co., Ltd.20200—
+4K193367elysion-proHigh Technology Products S.L.U20203—
+4K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+4K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+4K180508Joule SystemSciton, Inc20183—
+4K173199PicoSure WorkstationCynosure, Inc.20189—
+4K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+4K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+4K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+4K162755PicocareWontech Co., Ltd.20179—
+4K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+4K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+4K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+4K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+4K152856Helios IIILaseroptek Co., Ltd.20165—
+4K160480PicoSure WorkstationCynosure, Inc.201620—
+4K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+4K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+4K150326PicoWay Laser SystemCandela Corporation201568—
+4K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+4K141237Harmony LiteAlma, Inc.20154—
+4K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+4K143105Picosure WorkstationCynosure, Inc.201549—
+4K142372Pico Way Laser SystemCandela Corpation201470—
+4K140719Picosure WorkstationCynosure, Inc.201450—
+5K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+5K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+5K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+5K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+5K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+5K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+5K242206ActivoDaeju Meditech Engineering Co., Ltd.20240—
+5K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+5K233757TitanPico Laser Workstation (PICO-450)Rhein Laser Technologies Co., Ltd.20240—
+5K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+5K230308Alma HarmonyAlma Lasers, Inc.20232—
+5K223680Eneka ProTermosalud20230—
+5K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+5K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+5K222369PURE LaserEndymed Medical, Ltd.20220—
+5K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+5K212663Helios IV 785Laseroptek Co., Ltd.20223—
+5K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+5K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+5K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+5K202848S2 Pigment Removal SystemLightsense Technologies, Ltd.20210—
+5K210847UltraClear Fractional Laser SystemFa International, LP20210—
+5K203728DarwinLuvo Medical Technologies, Inc.20211—
+5K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+5K210226PicoSure WorkstationCynosure, LLC20213—
+5K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+5K202172StarWalkerFotona D.O.O.20203—
+5K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+5K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+5K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—
+5K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+5K191685PicoWay Laser SystemCandela Corporation201920—
+5K183392PicoLO Nd:YAG Picosecond Laser SystemLaseroptek Co., Ltd.20192—
+5K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+5K182997enlighten III Laser SystemCutera, Inc.20180—
+5K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+5K181272Picocare FamilyWontech Co., Ltd.20188—
+5K173700PICOPLUS Laser SystemLutronic Corporation20187—
+5K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+5K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+5K171227StarWalkerFotona D.O.O.20177—