510(k) Report

Devices descending from K963249

1,499 later devices reach Epilight Hair Removal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K221214Hand-held IPL device (IPL Home Use Hair Removal Device) Model:FZ-608, FZ-608G, FZ-100…Shenzhen Ionka Medical Technology Co., Ltd.202212—
+5K213267Dynamis Pro FamilyFotona D.O.O.20222—
+5K221635IPL sapphire ice cooling hair remove deviceShenzhen Desida Technology Co., Ltd.20220—
+5K221679IPL Hair Remover, Model: G993, G996, G998 and G885Shenzhen Mywin Technology Co., Ltd.20220—
+5K211979Lumenis Y&R Laser SystemLumenis, Inc.20220—
+5K210183Waterlase iPLusBiolase, Inc.20220—
+5K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+5K213558IPL Hair Removal DeviceUlike Co., Ltd.202215—
+5K211639BTL-785WBTL Industries, Inc.20227—
+5K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+5K210847UltraClear Fractional Laser SystemFa International, LP20210—
+5K212907Aimanfun Lumea Comfort, A-2789/A-3588Kam Yuen Plastic Products, Ltd.202114—
+5K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+5K213041IPL Hair Removal, Model: OBT-02Glan Electronics Co., Ltd.202115—
+5K212607DarwinLuvo Medical Technologies, Inc.20210—
+5K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+5K211174IPL Hair RemovalShenzhen Qiaochengli Technology Co., Ltd.20210—
+5K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+5K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+5K203054FlexSysGme German Medical Engineering GmbH20210—
+5K203299CellFX SystemPulse Biosciences, Inc.20214—
+5K202361UltraSlim Digital, UltraSmooth DigitalWard Photonics, LLC20200—
+5K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+5K193201BTL-785FBtl20208—
+5K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+5K200746IPL Treatment SystemsShanghai Apolo Medical Technology Co., Ltd.20205—
+5K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+5K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+5K193367elysion-proHigh Technology Products S.L.U20203—
+5K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+5K191693BC-5Reveallux, Corp20190—
+5K191942MT One DiamondM&T S.R.L.20191—
+5K190319Waterlase Laser System FamilyBiolase, Inc.201919—
+5K183708Poly ClearMedtek Skincare, LLC201922—
+5K191554LightWalker Laser System FamilyFotona D.O.O.201919—
+5K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+5K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+5K182930PerioLase Nd:YAG Pulsed Dental Laser SystemMillennium Dental Technologies, Inc.20190—
+5K190938Phototherapy SystemShanghai Apolo Medical Technology Co., Ltd.201916—
+5K183260Sensilight Pro / Pistol IPLEl Global Trade, Ltd.20190—
+5K180359BTL-FR2000BTL Industries, Inc.20189—
+5K181510Echolaser X4El.En Electronic Engineering Spa20183—
+5K172273308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20185—
+5K180518GME LinScan Lite 808 Laser SystemGme German Medical Engineering GmbH20181—
+5K180900LED Light Therapy DeviceUvbiotek, LLC201829—
+5K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+5K173692D-Actor 200 Vibration Massage SystemStorz Medical AG20186—
+5K173677InMode VLazeInmode MD, Ltd.20183—
+5K173759Thermage CPT System and AccessoriesSolta Medical201821
+5K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+5K171702Exciplex308nmClarteis20175—
+5K170758Thermage FLX System and AccessoriesSolta Medical201713—
+5K170179LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer InfinityLumenis, Ltd.201714—
+5K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+5K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+5K171055Philips BlueControlPhilips Electronics Nederland B.V.20171—
+5K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+5K160312Fraxis DuoIlooda Co,., Ltd.201614—
+5K161941Pulsaderm Acne DeviceNutra Luxe MD, LLC20164—
+5K160880Photonica ProfessionalWard Photonics, LLC20166—
+5K160075Accent XLAlma Lasers, Inc.20160—
+5K161669Waterlase ExpressBiolase, Inc.201621—
+5K152737Lite TouchFocus Medical, LLC20160—
+5K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+5K160968iPulse SmoothSkin Gold Hair Removal DeviceCyden Limited2016117—
+5K153566Magma SystemFormatk Systems, Ltd.20162—
+5K160368EVO platformQuanta System Spa201636—
+5K153081Clear Bi-LightMichael Todd, LP201646—
+5K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+5K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+5K151306SoleaConvergent Dental, Inc.20151—
+5K151655CO2RE SystemSyneron Medical, Ltd.20151—
+5K150907Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner…Ellipse A/S20155—
+5K140386Lumina 24Rogers Sciences, Inc.20150—
+5K150161Venus Viva SR DeviceVenus Concept, Ltd.20159—
+5K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+5K142256Applied BioPhotonics Phototherapy System ABPT1003Applied Biophotonics, Ltd.20150—
+5K142910Legacy BXVenus Concept USA, Inc.201411—
+5K143339Mini meIluminage Ltd.(Formerly Syneron Beauty Ltd.)20140—
+5K142340Infrared Therapy SystemBeijing Huatai Healthcare Technology Co., Ltd.20140—
+5K142093V20 SystemViora, Ltd.201432—
+5K140727Cutera Picosecond Laser SystemCutera, Inc.201447—
+5K141555AdvantageLutronic Corporation201414—
+5K142376Palomar Icon Aesthetic SystemCynosure, Inc.201413—
+5K133945Cutera Picosecond Laser SystemCutera, Inc.201414—
+5K133364Picosure WorkstationCynosure, Inc.201451—
+5K131757Tattoostar Effect ComboAsclepion Laser Technologies GmbH20140—
+5K140629Venus Swan (MP)2Venus Concept, Ltd.20140—
+5K140255Stop U (Packed Black Usa); Stop U (Packed White Usa)Pollogen, Ltd.20147—
+5K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+5K133201Shaser V-Mini 2 Hair Removal SystemShaser, Inc.201496—
+5K132989Speed 808 Diode Laser SystemBeijing Toplaser Technology Co., Ltd.20140—
+5K131837CO2 Fractional LaserBeijing Honkon Technologies Co., Ltd.20140—
+5K133283Candela Gentlemax Family of Laser SystemsCandela Corp.201313—
+5K124064Young AgainEspansione Marketing S.P.A20131—
+5K131758Surgen UPollogen, Ltd.20135—
+5K131095Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa201317—
+5K130199Clarity LPC Laser SystemLutronic Corporation20135—
+5K131859Multifunctional SeriesBeijing Honkon Technologies Co., Ltd.20133—
+5K130028Resurfx 1565NM Laser ModuleLumenis, Ltd.201341—