510(k) Report

Devices descending from K963947

1,546 later devices reach Epilaser Normal Mode Ruby Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K021650Athoscan for the Athos Laser Constans Cooling Hand Piece for the Athos LaserQuantel Medical20020—
+1K980517Epilaser Normal Mode Ruby LaserPalomar Medical Products, Inc.19981,509—
+1K974536Photoderm HR SystemEsc Medical Systems, Ltd.19981,496—
+1K980420LightsheerPalomar Medical Products, Inc.19981,494—
+1K980160Epilaser I Upgrade KitPalomar Medical Products, Inc.19980—
+1K973324Starlight Pulsed Diode Array Laser SystemStar Medical Technologies, Inc.19971,535—
+1K971193Laseaway Long Pulse and Q-Switched Ruby Laser SystemPolytec Pi, Inc.199739—
+2K121162Polaris Q-Switch Ruby SystemSandstone Medical Technologies, LLC201238—
+2K090762LEDAQuantel Derma GmbH200946—
+2K053527Spectra Hair Removal LaserSpectragenics, Inc.2008169—
+2K060448Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd.2006297—
+2K052848Spectra Hair Removal LaserSpectragenics, Inc.2005172—
+2K032846Spectra Pulsed Diode Laser, Model DR-1Spectragenics, Inc.2003173—
+2K023954Altus Medical Coolglide Laser Systems and AccessoriesAltus Medical, Inc.20031,117—
+2K013366Prolite Pulsed Light System for the Removal of Unwanted HairMedical Bio Care Sweden AB20021,129—
+2K011747Palomar LC 100 Diode LaserPalomar Medical Technologies, Inc.2001174—
+2K994260Candela Gentlelase GL Dermatological LaserCandela Corp.2000258—
+2K994225Palomar SLP 2000Palomar Medical Technologies, Inc.2000175—
+2K991798Acme Medical Aesthetic ND:Yag LaserAltus Medical2000745—
+2K991935Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd.20001,492—
+2K992298Iriderm, Model Apex 800Iridex Corp1999175—
+2K982940Lightsheer Pulsed Diode Array Laser SystemStar Medical Technologies, Inc.19991,526—
+2K982980Lightsheer Long Pulse Ruby LaserPalomar Medical Products, Inc.19991,493—
+2K983950Ceralas Diode Laser System (Model H)Ceram Optec, Inc.19990—
+3K200104OxylightRaja Trading Company, Inc.202024—
+3K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+3K152012EVO platformQuanta System Spa201537—
+3K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+3K142860Lumenis M22 SystemLumenis, Ltd.2015381
+3K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+3K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+3K132185Family of Coolglide Aesthetic LasersCutera, Inc.201336—
+3K123682Inmode Hair Removal (HR) DeviceInmode MD, Ltd.20131—
+3K111144Candela Gentlelase Family of LasersCandela Corp.201191—
+3K103184Silk'n Flash N GOHome Skinovations, Ltd.2010148—
+3K092734E-Light LineEspansione Marketing S.P.A20102—
+3K093465Fusion SystemEclipsemed Global, Inc.20100—
+3K090820Tria Hair Removal Laser SystemSpectragenics, Inc.2009167—
+3K083733Lume 2 System, Model GA0005000Lumenis, Ltd.200939—
+3K082298Flash N' GOHome Skinovations, Ltd.2008168—
+3K081408Ellipse MultiflexEllipse A/S20087—
+3K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008266—
+3K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+3K070388Profile Multi-Platform SystemSciton, Inc2007129—
+3K060839Abc Hair Removal SystemPalomar Medical Technologies, Inc.2006171—
+3K052371Depilite EL-8B Series Dermo Flash SystemsHair International Systems USA, Inc.20060—
+3K051876Multiwave XRPacific Quantum Instruments, Inc.20050—
+3K050293Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP Plus ND: Yag Family of…Fotona D.D.2005200—
+3K043255Ellipse Light SPTDanish Dermatologic Development A/S200525—
+3K050069Cutera Flashlamp Tabletop Aesthetic ProductCutera, Inc.20050—
+3K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd.2004517—
+3K042165Cutera Tabletop Aesthetic ProductCutera, Inc.20042411
+3K042474ARIONWavelight Laser Technologie AG2004114—
+3K041262Duralite-GLLaser Scientific20040—
+3K040617Reliant Laser System IIReliant Technologies, Inc.2004316—
+3K040384Mydon CWavelight Laser Technologie AG200451—
+3K033946Lovely SystemMsq (M2), Ltd.2004737—
+3K031671Polaris WRSyneron Medical, Ltd.2003678—
+3K032460Profile BBL SystemSciton, Inc2003569—
+3K033172Candela Gentleyag Family of Laser SystemsCandela Corp.2003654—
+3K032218Adept 1064/532/755 LaserAdept Medical Concepts2003104—
+3K032221Adept 1064/755 LaserAdept Medical Concepts20030—
+3K032220Adept 1064/532 LaserAdept Medical Concepts2003126—
+3K031828Naturalase LP ND:Yag LaserFocus Medical, LLC20035—
+3K031680SpectrapulsePrimary Technology, LLC20030—
+3K023881Profile 1064 Laser SystemSciton, Inc2003227—
+3K030508Depilase Trio Lase Laser SystemDepilase Group, Ltd.20030—
+3K024371Candela Gentle Lase Family of Laser SystemCandela Corp.2003207—
+3K024260Candela Gentlelase Family of Laser SystemsCandela Corp.20031861
+3K024335Candela Gentlelase Family of Laser SystemsCandela Corp.20031871
+3K023081Prolite / Plasmalite MPX Pulsed Light System (Permanent Hair Reduction)Medical Bio Care Sweden AB200223—
+3K022378Plasmalite Pulsed Light SystemMedical Bio Care Sweden AB20020—
+3K020839Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DLLumenis, Inc.20021,046—
+3K022226Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future…Altus Medical, Inc.2002665—
+3K022568Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted HairMedical Bio Care Sweden AB20021,127—
+3K021149Aurora DSSyneron Medical, Ltd.2002750—
+3K014040Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide I, II and…Altus Medical, Inc.2002739—
+3K020849Apex 800 Laser System, Model Apex 800Iridex Corp2002174—
+3K020453Palomar Estelux Pulsed Light System and Palomar CoolrollerPalomar Medical Technologies, Inc.20021,018—
+3K020697Depilase Twin Yag Laser SystemDepilase Group, Ltd.2002229—
+3K020463Depilase Yag Lase Plus Laser SystemDepilase Group, Ltd.20021—
+3K020412Depilase Twin Lase Laser SystemDepilase Group, Ltd.2002106—
+3K994116Laser System Mediostar H (with and Without Skin Cooling System)Aesculap-Meditec North America20000—
+4K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+4K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) Co., Ltd.20250—
+4K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+4K233024Alma HarmonyAlma Lasers, Inc.20241—
+4K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd.20230—
+4K231054V-LaserWontech Co., Ltd.20231—
+4K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+4K230308Alma HarmonyAlma Lasers, Inc.20232—
+4K220214Painless IPL System - KDT750Shanghai Omni Laser Skinology Co., Ltd.20230—
+4K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+4K223540AvalancheLase FamilyFotona D.O.O.20230—
+4K213105Epilaser AbsoluteEpilady 2000, LLC20221—
+4K213350mJOULE System and AccessoriesSciton, Inc20220—
+4K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+4K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+4K202288FinebeamSNJ Co., Ltd.20212—
+4K203788DermaV Laser SystemLutronic Corporation202101