510(k) Report

Devices descending from K060033

221 later devices reach Profile Multi-Platform System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213761Joule diVa SystemSciton, Inc20220—
+1K141975Waterlase Iplus SBiolase, Inc.20150—
+1K122368Waterlase Iplus All Tissue LaserBiolase Technology, Inc.20130—
+1K101916Joule Multi-Platform SystemSciton, Inc2011111—
+1K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+1K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc.2008202—
+1K070388Profile Multi-Platform SystemSciton, Inc2007129—
+1K070138Cutera ER:Yag Laser HandpieceCutera, Inc.20071—
+1K063867Cutera ER:Ysgg Laser HandpieceCutera, Inc.20072—
+2K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+2K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+2K193656SkyPulseFotona D.O.O.202011—
+2K173285Joule SystemSciton, Inc20185—
+2K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+2K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+2K132976AdvatxAdvalight Aps20141—
+2K110364Dornier Medilas D Litebeam+ 1470Dornier Medtech America, Inc.20117—
+2K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+2K101573Accusculpt II Laser SystemLutronic Corporation20101—
+2K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+2K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+2K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+2K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+2K081352Profile Multi-Platform SystemSciton, Inc2008112—
+2K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+2K080530Modification to Cutera ER:Ysgg Laser HandpieceCutera, Inc.20081—
+2K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+2K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+3K252658Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd.20251—
+3K250261Heager Medical Laser Family (Sabrina/Adolf)Heager GmbH20250—
+3K250189AdvaTxAdvalight Aps20250—
+3K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+3K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+3K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+3K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+3K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+3K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+3K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+3K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+3K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+3K210183Waterlase iPLusBiolase, Inc.20220—
+3K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+3K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+3K193367elysion-proHigh Technology Products S.L.U20203—
+3K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+3K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+3K180508Joule SystemSciton, Inc20183—
+3K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+3K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+3K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+3K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+3K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+3K141237Harmony LiteAlma, Inc.20154—
+3K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+3K133774AtovenBio-Med USA, Inc.20146—
+3K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+3K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+3K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+3K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+3K100558Quanta Diode Laser SystemQuanta System Spa201068—
+3K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+3K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+4K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+4K261964Echolaser X4Elesta S.P.A20260—
+4K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+4K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+4K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+4K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+4K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+4K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+4K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—
+4K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+4K233344Regenalase Laser SystemIpg Medical20240—
+4K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+4K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+4K230308Alma HarmonyAlma Lasers, Inc.20232—
+4K223680Eneka ProTermosalud20230—
+4K222701MANTA LaserSqualus Med, Ltd.20222—
+4K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+4K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+4K222369PURE LaserEndymed Medical, Ltd.20220—
+4K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+4K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+4K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+4K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+4K210847UltraClear Fractional Laser SystemFa International, LP20210—
+4K203728DarwinLuvo Medical Technologies, Inc.20211—
+4K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+4K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+4K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+4K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+4K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+4K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+4K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+4K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+4K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+4K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+4K171227StarWalkerFotona D.O.O.20177—
+4K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+4K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—