510(k) Report

Devices descending from K010285

524 later devices reach Contour Profile Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+4K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+4K172413MT ONEM&T S.R.L.20175—
+4K163196ACTION II Laser SystemLutronic Corporation20170—
+4K160075Accent XLAlma Lasers, Inc.20160—
+4K152714Quanta ForteQuanta System Spa201513—
+4K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+4K151655CO2RE SystemSyneron Medical, Ltd.20151—
+4K150161Venus Viva SR DeviceVenus Concept, Ltd.20159—
+4K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+4K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+4K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+4K142376Palomar Icon Aesthetic SystemCynosure, Inc.201413—
+4K133837Viora V-TotalViora, Ltd.201433—
+4K130501IntensifEndymed Medical, Ltd.201457—
+4K131758Surgen UPollogen, Ltd.20135—
+4K130028Resurfx 1565NM Laser ModuleLumenis, Ltd.201341—
+4K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+4K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—
+4K120622Palomar Vectus LaserPalomar Medical Technologies, Inc.20124—
+4K120513Glow by EndymedEndymed Medical, Ltd.20125—
+4K110364Dornier Medilas D Litebeam+ 1470Dornier Medtech America, Inc.20117—
+4K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+4K110672Etwo Skin Treatment SystemSyneron, Ltd.20112—
+4K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+4K102954Cutera Qswitch Laser SystemCutera, Inc.201149—
+4K103288Deka Synchro FTEl.En Electronic Engineering Spa201118—
+4K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc.2010921
+4K101573Accusculpt II Laser SystemLutronic Corporation20101—
+4K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+4K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+4K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+4K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+4K081352Profile Multi-Platform SystemSciton, Inc2008112—
+4K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+4K080530Modification to Cutera ER:Ysgg Laser HandpieceCutera, Inc.20081—
+4K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+4K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+5K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+5K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+5K260153Q-Switched Nd: YAG Laser System (Glamor Q)Nanjing Bestview Laser S&T Co., Ltd.20260—
+5K260632Laser Thermal Therapy KitElesta S.P.A20260—
+5K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+5K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+5K252658Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd.20251—
+5K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+5K250261Heager Medical Laser Family (Sabrina/Adolf)Heager GmbH20250—
+5K250165PastelleWontech Co., Ltd.20250—
+5K251632Optimas MAX SystemInMode, Ltd.20251—
+5K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+5K250722Nd: YAG Laser Therapy System (QN-1)Hebei JT Medical Co., Ltd.20250—
+5K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+5K250281Deka LotusEl.En S.P.A.20250—
+5K241270BTL-754BTL Industries, Inc.20251—
+5K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+5K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+5K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+5K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+5K230077LaserMENeauvia North America20232—
+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—
+5K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+5K213594Echolaser X4Elesta S.P.A20221—
+5K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+5K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+5K210847UltraClear Fractional Laser SystemFa International, LP20210—
+5K202288FinebeamSNJ Co., Ltd.20212—
+5K212607DarwinLuvo Medical Technologies, Inc.20210—
+5K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+5K211444CellFX SystemPulse Biosciences, Inc.20213—
+5K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+5K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+5K202988Tixel SystemNovoxel, Ltd.20211—
+5K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+5K193201BTL-785FBtl20208—
+5K201164Venus Viva MD DeviceVenus Concept USA, Inc.20203—
+5K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+5K191065Venus VivaTMVenus Concept USA, Inc.20200—
+5K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+5K193426Elite iQCynosure, LLC20201—
+5K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+5K191942MT One DiamondM&T S.R.L.20191—
+5K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+5K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+5K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+5K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+5K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+5K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+5K171227StarWalkerFotona D.O.O.20177—
+5K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+5K162765Venus Velocity Diode Laser SystemVenus Concept, Ltd.20171—
+5K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+5K160312Fraxis DuoIlooda Co,., Ltd.201614—
+5K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+5K153717Venus Versa SystemVenus Concept, Ltd.20161—
+5K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+5K151273InMode FRF ApplicatorInmode MD, Ltd.20163—