510(k) Report

Devices descending from K980517

1,509 later devices reach Epilaser Normal Mode Ruby Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K200616E>EyeCE-Swin20200—
+5K200746IPL Treatment SystemsShanghai Apolo Medical Technology Co., Ltd.20205—
+5K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+5K193656SkyPulseFotona D.O.O.202011—
+5K193367elysion-proHigh Technology Products S.L.U20203—
+5K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+5K191693BC-5Reveallux, Corp20190—
+5K183708Poly ClearMedtek Skincare, LLC201922—
+5K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+5K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+5K190938Phototherapy SystemShanghai Apolo Medical Technology Co., Ltd.201916—
+5K183566CLARITY II Laser SystemLutronic Corporation201911
+5K183260Sensilight Pro / Pistol IPLEl Global Trade, Ltd.20190—
+5K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+5K182663Nobleen Long Pulsed Alexandrite & Nd: YAG Laser SystemFinemec Co., Ltd.20180—
+5K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+5K181510Echolaser X4El.En Electronic Engineering Spa20183—
+5K180900LED Light Therapy DeviceUvbiotek, LLC201829—
+5K180593Vbeam Prima Laser SystemSyneron-Candela20182—
+5K180508Joule SystemSciton, Inc20183—
+5K173692D-Actor 200 Vibration Massage SystemStorz Medical AG20186—
+5K173677InMode VLazeInmode MD, Ltd.20183—
+5K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+5K172819LightWalker Laser System FamilyFotona D.O.O.201720—
+5K172413MT ONEM&T S.R.L.20175—
+5K170179LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer InfinityLumenis, Ltd.201714—
+5K171227StarWalkerFotona D.O.O.20177—
+5K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+5K171055Philips BlueControlPhilips Electronics Nederland B.V.20171—
+5K163196ACTION II Laser SystemLutronic Corporation20170—
+5K161941Pulsaderm Acne DeviceNutra Luxe MD, LLC20164—
+5K160880Photonica ProfessionalWard Photonics, LLC20166—
+5K160227ACCENTO / HWA Dual/Single laserBison Medical Co, Ltd.20160—
+5K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+5K160968iPulse SmoothSkin Gold Hair Removal DeviceCyden Limited2016117—
+5K153566Magma SystemFormatk Systems, Ltd.20162—
+5K153081Clear Bi-LightMichael Todd, LP201646—
+5K152714Quanta ForteQuanta System Spa201513—
+5K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+5K152012EVO platformQuanta System Spa201537—
+5K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+5K150907Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner…Ellipse A/S20155—
+5K150140MCL 31 DermablateAsclepion Laser Technologies GmbH20157—
+5K140386Lumina 24Rogers Sciences, Inc.20150—
+5K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa201516—
+5K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+5K141975Waterlase Iplus SBiolase, Inc.20150—
+5K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+5K142256Applied BioPhotonics Phototherapy System ABPT1003Applied Biophotonics, Ltd.20150—
+5K141868Tria FanpTria Beauty, Inc.20140—
+5K143339Mini meIluminage Ltd.(Formerly Syneron Beauty Ltd.)20140—
+5K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+5K140926Inmode Wmface DeviceInmode MD, Ltd.20143—
+5K142340Infrared Therapy SystemBeijing Huatai Healthcare Technology Co., Ltd.20140—
+5K140732Candela Gentlelase Family of Laser SystemsCandela Corp.20141—
+5K141555AdvantageLutronic Corporation201414—
+5K142376Palomar Icon Aesthetic SystemCynosure, Inc.201413—
+5K131757Tattoostar Effect ComboAsclepion Laser Technologies GmbH20140—
+5K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+5K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+5K133405MinnieElettronica Valseriana Srl20140—
+5K140122Candela Gentlemax Family of Laser SystemCandela Corp.201410—
+5K133837Viora V-TotalViora, Ltd.201433—
+5K130501IntensifEndymed Medical, Ltd.201457—
+5K133201Shaser V-Mini 2 Hair Removal SystemShaser, Inc.201496—
+5K132286Hyperion Long Pulsed ND: Yag LaserScarlet Rf, Inc.20143—
+5K124064Young AgainEspansione Marketing S.P.A20131—
+5K131142Genesis Led WandsGenesis Biosystems, Inc.20130—
+5K131859Multifunctional SeriesBeijing Honkon Technologies Co., Ltd.20133—
+5K132431Thermage CPT SystemSolta Medical, Inc.2013171
+5K130028Resurfx 1565NM Laser ModuleLumenis, Ltd.201341—
+5K123999Illumask Acne Light Therapy MaskLa Lumiere, LLC2013112—
+5K130793Newa Skin Therapy SystemEndymion Medical, Ltd.20130—
+5K122493GenesisplusCutera, Inc.201318—
+5K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+5K122368Waterlase Iplus All Tissue LaserBiolase Technology, Inc.20130—
+5K122200A3F FrationalPollogen, Ltd.20130—
+5K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—
+5K123682Inmode Hair Removal (HR) DeviceInmode MD, Ltd.20131—
+5K121435Silkn BlueHome Skinovations, Ltd.2013125—
+5K123435Ipl Therapy SystemBeijing Sincoheren S&T Development Co, Ltd.20130—
+5K122995Intense Pulsed Light (Ipl) SystemsBeijing Kes Biology Technology Co., Ltd.201316—
+5K122237Biophotas LifelightBiophotas, Inc.201371—
+5K121508Lightwalker at Lightwalker DT Lightwalker ST-E Lightwalker ST-NFotona D.D.20121—
+5K113843Freedom ND: Yag Laser SystemLutronic Corporation20120—
+5K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc.20123—
+5K120235Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag Lasers, Friendlylight Neo…Aerolase Medical Lasers, LLC201233—
+5K120622Palomar Vectus LaserPalomar Medical Technologies, Inc.20124—
+5K120513Glow by EndymedEndymed Medical, Ltd.20125—
+5K113702Fotona XP ND: Yag Laser SystemFotona D.D.201265—
+5K111670Venus Freeze (MP)2 SystemVenus Concept, Ltd.201213—
+5K111286Quasar CalypsoSilver Bay, LLC201276—
+5K111483Joule Clearsense Laser SystemSciton, Inc20110—
+5K111026ApolloPollogen, Ltd.201114—
+5K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+5K111784Venus Swan SystemVenus Concept, Ltd.20111—
+5K110672Etwo Skin Treatment SystemSyneron, Ltd.20112—
+5K110301Silk'n FXHome Skinovations, Ltd.201166—
+5K102954Cutera Qswitch Laser SystemCutera, Inc.201149—
+5K102461FractoraInvasix, Ltd.201124—