510(k) Report

Devices descending from K972767

1,179 later devices reach Candela Gentlelase GL Dermatological Vascular Lesion Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+6K142256Applied BioPhotonics Phototherapy System ABPT1003Applied Biophotonics, Ltd.20150—
+6K142340Infrared Therapy SystemBeijing Huatai Healthcare Technology Co., Ltd.20140—
+6K140249Long Pulse ND: Yag Laser SystemAdvanced Technology Laser Co., Ltd.20143—
+6K142376Palomar Icon Aesthetic SystemCynosure, Inc.201413—
+6K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+6K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+6K133837Viora V-TotalViora, Ltd.201433—
+6K124064Young AgainEspansione Marketing S.P.A20131—
+6K131142Genesis Led WandsGenesis Biosystems, Inc.20130—
+6K130459Tria Fan SystemTria Beauty, Inc.20131—
+6K131859Multifunctional SeriesBeijing Honkon Technologies Co., Ltd.20133—
+6K130028Resurfx 1565NM Laser ModuleLumenis, Ltd.201341—
+6K123999Illumask Acne Light Therapy MaskLa Lumiere, LLC2013112—
+6K122493GenesisplusCutera, Inc.201318—
+6K122368Waterlase Iplus All Tissue LaserBiolase Technology, Inc.20130—
+6K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—
+6K123682Inmode Hair Removal (HR) DeviceInmode MD, Ltd.20131—
+6K121435Silkn BlueHome Skinovations, Ltd.2013125—
+6K123435Ipl Therapy SystemBeijing Sincoheren S&T Development Co, Ltd.20130—
+6K122995Intense Pulsed Light (Ipl) SystemsBeijing Kes Biology Technology Co., Ltd.201316—
+6K122237Biophotas LifelightBiophotas, Inc.201371—
+6K121508Lightwalker at Lightwalker DT Lightwalker ST-E Lightwalker ST-NFotona D.D.20121—
+6K113843Freedom ND: Yag Laser SystemLutronic Corporation20120—
+6K120235Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag Lasers, Friendlylight Neo…Aerolase Medical Lasers, LLC201233—
+6K120622Palomar Vectus LaserPalomar Medical Technologies, Inc.20124—
+6K112669Tattoostar Effect YAsclepion Laser Technologies GmbH20128—
+6K113115Epicare YagLight Age, Inc.20120—
+6K113702Fotona XP ND: Yag Laser SystemFotona D.D.201265—
+6K111286Quasar CalypsoSilver Bay, LLC201276—
+6K111483Joule Clearsense Laser SystemSciton, Inc20110—
+6K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+6K110301Silk'n FXHome Skinovations, Ltd.201166—
+6K101306SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP Spectro, Models…Fotona D.D.201178—
+6K102954Cutera Qswitch Laser SystemCutera, Inc.201149—
+6K103455Spectra Laser SystemLutronic Corporation201192—
+6K110304Apex ER. Yag / Ipl SystemSandstone Medical Technologies, LLC20112—
+6K103288Deka Synchro FTEl.En Electronic Engineering Spa201118—
+6K102857Ahwon's Ipl SystemAhwon Medi Instrument Co., Ltd.20112—
+6K103415Tanda MaxPharos Life Corporation20110—
+6K100628PlasmaluxlsDaavlin Distributing Co.20100—
+6K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc.2010921
+6K101321Ematrix CO2Syneron Medical, Ltd.20102—
+6K101573Accusculpt II Laser SystemLutronic Corporation20101—
+6K091467Baby QuasarSilver Bay, LLC20100—
+6K101506LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc.2010156—
+6K093168Mediflash and EsteflashDermeo20100—
+6K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+6K090744CLAROClrs Technology Corporation20101—
+6K092460Star-Lite -LM, Model SL8809Ps Advanced Engineering20101—
+6K092800Anti-Wrinkle (Aging) Light, Model AalLed Intellectual Properties, LLC201011—
+6K093162Fidelis Plus Iii D, at Fidelis D, Powerlase at D / Fidelis Plus Iii, at Fidelis…Fotona D.D.201083—
+6K090312Tria Acne Treatment System, Model Ats-1 OtcTria Beauty, Inc.20101—
+6K091664GSD Intense Pulsed Light System, Models: GP666C4, GP666CShenzhen Gsd Tech Co., Ltd.20094—
+6K090724OR-LightYperion Technology20090—
+6K091534Lightlas Model 532Lightmed Corp.200972—
+6K083183Aklarus Phototherapy SystemHill Laboratories Co.200991—
+6K083008CoolskinElbio Co., Ltd.20092—
+6K090525Loi SystemPalomar Medical Products, Inc.20099—
+6K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+6K083730IsolazAesthera Corporation20093—
+6K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+6K080118Zeltiq Aesthetics CLN1 Dermal Cooling DeviceZeltiq Aesthetics200833—
+6K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+6K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+6K080735CryominiZimmer Elektromedizin GmbH20081—
+6K070355Fotona Fidelis Iii ER:Yag/ND:Yag Laser System FamilyFotona D.D.2008194—
+6K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc.2008202—
+6K072344Apl Medical SystemBios S.R.L.20076—
+6K071051Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007194—
+6K063427Lumina Intense Pulsed Light (& Laser) SystemLynton Lasers Limited20070—
+6K070284Fralex SR 1500 Laser System (Fralex II SR Laser System)Reliant Technologies, Inc.2007172—
+6K063808Fraxel IV SR Laser SystemReliant Technologies, Inc.200734—
+6K063038Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007195—
+6K070138Cutera ER:Yag Laser HandpieceCutera, Inc.20071—
+6K063867Cutera ER:Ysgg Laser HandpieceCutera, Inc.20072—
+6K062303Fraxel II SR Laser SystemReliant Technologies, Inc.2007226—
+6K063249BeamaxMedic Sharplight, Ltd.200758—
+6K060977Medlite C Series Compression Tool and Handpiece Attachment Accessory, Model 659-0523Hoya Conbio, Inc.20060—
+6K060310Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc.2006230—
+6K053047Fraxel SR Laser SystemReliant Technologies, Inc.2006205—
+6K052442Radiancy Skinstation with Psoriasis Light Unit AssemblyRadiancy (Israel), Ltd.200612—
+6K053324Chromolite SystemChromogenex Plc200631—
+6K051681Dermillume Red, Model HR1000Care Electronics, Inc.20053—
+6K050218Wavelight SinonWavelight Laser Technologie AG20050—
+6K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd.2004517—
+6K041969Aurora DSSyneron Medical, Ltd.2004302—
+6K033172Candela Gentleyag Family of Laser SystemsCandela Corp.2003654—
+7K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.20260—
+7K261964Echolaser X4Elesta S.P.A20260—
+7K261674Skin Air Cooling System (QALF-01)Beijing Nubway S&T Co., Ltd.20260—
+7K254025LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+7K261204Intense Pulsed Light Therapy DeviceSanhe LEFIS Electronics Co., Ltd.20260—
+7K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+7K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+7K253765Vanish ProDdc Technologies, Inc.20260—
+7K260153Q-Switched Nd: YAG Laser System (Glamor Q)Nanjing Bestview Laser S&T Co., Ltd.20260—
+7K253342PICO-KSpeclipse, Inc.20251—
+7K252994LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7…Guangdong Ace-Tec Co., Ltd.20250—
+7K253344Bellus-QSpeclipse, Inc.20250—