510(k) Report

Devices descending from K020958

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K033331Candela Cbeam Pulse Dye Laser SystemCandela Corp.2004230—
+2K070388Profile Multi-Platform SystemSciton, Inc2007129—
+2K053047Fraxel SR Laser SystemReliant Technologies, Inc.2006205—
+2K043251Candela Family of Pulsed Dye Laser Systems, Models Vbeam, Cbeam, SPTL-1BCandela Corp.2005136—
+3K132976AdvatxAdvalight Aps20141—
+3K101916Joule Multi-Platform SystemSciton, Inc2011111—
+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—
+3K051359Candela Family of Pulsed Dye Laser Systems: Pigmented Lesion Handpiece AccessoryCandela Corp.200511
+3K050673Candela Family of Pulse Dye Laser SystemsCandela Corp.20051332
+4K250189AdvaTxAdvalight Aps20250—
+4K230990Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)Candela Corporation20230—
+4K213761Joule diVa SystemSciton, Inc20220—
+4K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+4K193656SkyPulseFotona D.O.O.202011—
+4K180593Vbeam Prima Laser SystemSyneron-Candela20182—
+4K173285Joule SystemSciton, Inc20185—
+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—
+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—
+4K060977Medlite C Series Compression Tool and Handpiece Attachment Accessory, Model 659-0523Hoya Conbio, Inc.20060—
+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—
+5K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+5K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+5K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+5K233550MOSAIC 3D (Surgical Laser)Lutronic Aesthetic20240—
+5K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+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—
+5K210183Waterlase iPLusBiolase, Inc.20220—
+5K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+5K193367elysion-proHigh Technology Products S.L.U20203—
+5K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+5K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+5K183452Vbeam Prima Laser SystemCandela Corp.20191—
+5K180508Joule SystemSciton, Inc20183—
+5K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+5K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+5K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+5K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+5K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+5K151655CO2RE SystemSyneron Medical, Ltd.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—
+5K131837CO2 Fractional LaserBeijing Honkon Technologies Co., Ltd.20140—
+5K132754Neogen PSR SystemEnergist, Ltd.20132—
+5K123573Youlaser CO2 LaserQuanta System Spa201319—
+5K110333Naturalase CO2 Laser SystemFocus Medical, LLC20121—
+5K101152Naturalase Diode Laser Family Naturalase Model NL980, Naturalase Diode Laser Family…Focus Medical, LLC20100—
+5K091115ECO2 Laser SystemLutronic Corporation200927—
+5K090639EXELO2, Model 4010Quantel Derma GmbH20090—
+5K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+5K083900Erbium Fractional HandpiecePalomar Medical Products, Inc.2009158—
+6K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+6K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+6K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+6K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+6K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+6K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+6K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+6K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+6K230308Alma HarmonyAlma Lasers, Inc.20232—
+6K223680Eneka ProTermosalud20230—
+6K221873NeoGen PSR SystemEnergist Limited20230—
+6K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+6K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+6K222369PURE LaserEndymed Medical, Ltd.20220—
+6K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+6K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+6K211652Renuvion Dermal Handpiece, Renuvion Dermal SystemApyx Medical Corporation (Formerly Bovie Medical Corporation20220—
+6K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+6K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+6K210847UltraClear Fractional Laser SystemFa International, LP20210—
+6K203728DarwinLuvo Medical Technologies, Inc.20211—
+6K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+6K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+6K192856MT OneM&T S.R.L.20202—
+6K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+6K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+6K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+6K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+6K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+6K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—