510(k) Report

Devices descending from K021180

318 later devices reach Candela Vbeam Pulsed Dye Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198—
+1K043251Candela Family of Pulsed Dye Laser Systems, Models Vbeam, Cbeam, SPTL-1BCandela Corp.2005136—
+1K032397Dual Yellow Laser, Model Dual Yellow D10BNorseld Pty., Ltd.20042—
+1K033461Candela Vbeam Pulse Dye Laser SystemCandela Corp.2004316—
+2K150907Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner…Ellipse A/S20155—
+2K132976AdvatxAdvalight Aps20141—
+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
+2K070388Profile Multi-Platform SystemSciton, Inc2007129—
+2K053047Fraxel SR Laser SystemReliant Technologies, Inc.2006205—
+2K051359Candela Family of Pulsed Dye Laser Systems: Pigmented Lesion Handpiece AccessoryCandela Corp.200511
+2K050673Candela Family of Pulse Dye Laser SystemsCandela Corp.20051332
+3K250165PastelleWontech Co., Ltd.20250—
+3K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+3K250189AdvaTxAdvalight Aps20250—
+3K230990Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)Candela Corporation20230—
+3K213761Joule diVa SystemSciton, Inc20220—
+3K202288FinebeamSNJ Co., Ltd.20212—
+3K192856MT OneM&T S.R.L.20202—
+3K193656SkyPulseFotona D.O.O.202011—
+3K180593Vbeam Prima Laser SystemSyneron-Candela20182—
+3K173285Joule SystemSciton, Inc20185—
+3K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+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—
+3K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+3K121346Picosure WorkstationCynosure, Inc.201287—
+3K101573Accusculpt II Laser SystemLutronic Corporation20101—
+3K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+3K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+3K081352Profile Multi-Platform SystemSciton, Inc2008112—
+3K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+3K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+3K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+3K073111Portrait PSR, Model 745915Rhytec Incorporated20084—
+3K071051Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007194—
+3K070392Mosaic Laser SystemLutronic Corporation20078—
+3K063038Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007195—
+3K060977Medlite C Series Compression Tool and Handpiece Attachment Accessory, Model 659-0523Hoya Conbio, Inc.20060—
+4K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+4K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+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—
+4K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+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—
+4K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+4K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+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—
+4K183452Vbeam Prima Laser SystemCandela Corp.20191—
+4K180508Joule SystemSciton, Inc20183—
+4K180406Ellipse YdunEllipse A/S20180—
+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—
+4K101321Ematrix CO2Syneron Medical, Ltd.20102—
+4K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+4K082197Rhytec, Inc., Portrait PSRRhytec Incorporated20083—
+4K080496Mosaic ECO2 Laser SystemLutronic Corporation200830—
+4K080915Fraxel RE:Pair (Fraxel Iii SR) Laser System and AccessoriesReliant Technologies, Inc.2008187—
+4K080932Mosaic Laser SystemLutronic Corporation20086—
+4K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+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—