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
+6K142093V20 SystemViora, Ltd.201432—
+6K140732Candela Gentlelase Family of Laser SystemsCandela Corp.20141—
+6K140727Cutera Picosecond Laser SystemCutera, Inc.201447—
+6K142376Palomar Icon Aesthetic SystemCynosure, Inc.201413—
+6K133945Cutera Picosecond Laser SystemCutera, Inc.201414—
+6K133364Picosure WorkstationCynosure, Inc.201451—
+6K131757Tattoostar Effect ComboAsclepion Laser Technologies GmbH20140—
+6K140629Venus Swan (MP)2Venus Concept, Ltd.20140—
+6K140255Stop U (Packed Black Usa); Stop U (Packed White Usa)Pollogen, Ltd.20147—
+6K140122Candela Gentlemax Family of Laser SystemCandela Corp.201410—
+6K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+6K133201Shaser V-Mini 2 Hair Removal SystemShaser, Inc.201496—
+6K132989Speed 808 Diode Laser SystemBeijing Toplaser Technology Co., Ltd.20140—
+6K131837CO2 Fractional LaserBeijing Honkon Technologies Co., Ltd.20140—
+6K131758Surgen UPollogen, Ltd.20135—
+6K131859Multifunctional SeriesBeijing Honkon Technologies Co., Ltd.20133—
+6K130028Resurfx 1565NM Laser ModuleLumenis, Ltd.201341—
+6K123999Illumask Acne Light Therapy MaskLa Lumiere, LLC2013112—
+6K120510TranscendSyneron Medical, Ltd.201318—
+6K130420SOLEAConvergent Dental, Inc.201321
+6K130193Fraxel Dual 1550/1927 Laser SystemSolta Medical, Inc.201325—
+6K123971Cynosure 1064NM Diode LaserCynosure, Inc.201325—
+6K123573Youlaser CO2 LaserQuanta System Spa201319—
+6K122966XP200Btl Industries, 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—
+6K123257Emvera DioluxEmvera Technologies, Inc.20123—
+6K121346Picosure WorkstationCynosure, Inc.201287—
+6K121286EPIC 10Biolase Technology, Inc.201231—
+6K120377Adverl Evo ER: Yag Laser for Dentistry Mey-1-aJ. Morita USA, Inc.20122—
+6K120622Palomar Vectus LaserPalomar Medical Technologies, Inc.20124—
+6K110333Naturalase CO2 Laser SystemFocus Medical, LLC20121—
+6K120433Clear + Brilliant Laser SystemSolta Medical, Inc.20121—
+6K113588Spectra Laser SystemLutronic Corporation201282—
+6K111286Quasar CalypsoSilver Bay, LLC201276—
+6K110364Dornier Medilas D Litebeam+ 1470Dornier Medtech America, Inc.20117—
+6K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+6K103547Lightlas Multi-Wavelength Medical Laser SystemLightmed Corp.20112—
+6K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+6K112031Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for Use with the Family…Alma Lasers, Inc.2011118—
+6K110301Silk'n FXHome Skinovations, Ltd.201166—
+6K110349Clear+Brilliant Laser SystemSolta Medical, Inc.20116—
+6K110304Apex ER. Yag / Ipl SystemSandstone Medical Technologies, LLC20112—
+6K102857Ahwon's Ipl SystemAhwon Medi Instrument Co., Ltd.20112—
+6K102698Pelleve Glidesafe Non-Ablative Wrinkle Treatment System Model Pelleve GlidesafeEllman Int'L, Inc.201139—
+6K103415Tanda MaxPharos Life Corporation20110—
+6K100628PlasmaluxlsDaavlin Distributing Co.20100—
+6K091467Baby QuasarSilver Bay, LLC20100—
+6K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+6K102368Non-Ablative Wrinkle Treatment HandpieceEllman Int'L, Inc.201052—
+6K101152Naturalase Diode Laser Family Naturalase Model NL980, Naturalase Diode Laser Family…Focus Medical, LLC20100—
+6K100558Quanta Diode Laser SystemQuanta System Spa201068—
+6K093168Mediflash and EsteflashDermeo20100—
+6K090744CLAROClrs Technology Corporation20101—
+6K092460Star-Lite -LM, Model SL8809Ps Advanced Engineering20101—
+6K092800Anti-Wrinkle (Aging) Light, Model AalLed Intellectual Properties, LLC201011—
+6K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+6K090312Tria Acne Treatment System, Model Ats-1 OtcTria Beauty, Inc.20101—
+6K091664GSD Intense Pulsed Light System, Models: GP666C4, GP666CShenzhen Gsd Tech Co., Ltd.20094—
+6K091115ECO2 Laser SystemLutronic Corporation200927—
+6K090639EXELO2, Model 4010Quantel Derma GmbH20090—
+6K091446Modification to LUX1540 Handpiece and Lux 1440 HandpiecePalomar Medical Products, Inc.2009158—
+6K092195Cutera Multimodal Cellulite Product (Cmmcd)Cutera, Inc.20090—
+6K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+6K083183Aklarus Phototherapy SystemHill Laboratories Co.200991—
+6K090221Reaction SystemViora, Ltd.200954—
+6K090580Thermage Thermacool NXT System and AccessoriesSolta Medical, Inc.200919—
+6K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+6K091323Modified Intermedic Diode Laser 980NM System (Multidiode SST 200)Intermedic Arfran, SA20090—
+6K090525Loi SystemPalomar Medical Products, Inc.20099—
+6K083730IsolazAesthera Corporation20093—
+6K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+6K080530Modification to Cutera ER:Ysgg Laser HandpieceCutera, Inc.20081—
+6K080932Mosaic Laser SystemLutronic Corporation20086—
+6K080300Cutera Multimodal Cellulite Product (Cmmcd)Cutera, Inc.2008101—
+6K073111Portrait PSR, Model 745915Rhytec Incorporated20084—
+6K073583Modification to Palomar LUX1540 HandpiecePalomar Medical Products, Inc.2008159—
+6K072925Candela-Inolase Serenity Pro PSF SystemInolase, Ltd.20080—
+6K072034Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa2007263—
+6K072152Juniper CLN1 Dermal Cooling DeviceJuniper Medical, Inc.200734—
+6K072106150W Ceralas D 980NM Diode LaserBiolitec, Inc.2007229—
+6K071872VelashapeSyneron Medical, Ltd.2007127—
+6K071469Inolase Serenity PSF ( Pneumatic Skin Flattening) SystemCandela Corp.20071—
+6K071943Serenity Pro PSF SystemInolase 2002, Ltd.20071—
+6K070092Modification to Velasmooth, ShaperSyneron Medical, Ltd.2007128—
+6K071295100W Ceralas D 980NM Diode LaserBiolitec, Inc.2007230—
+6K063715Juniper Cooling Device XtraJuniper Medical, Inc.200735—
+6K063396Velure Family of Diode Lasers and Delivery Device AccessoriesLasering S.R.L.200722—
+6K061603SmoothshapesBiocellulase, Inc.200648—
+6K053611SmoothshapesBicellulase, Inc.200695—
+6K052324Polaris LV, Lva ApplicatorSyneron Medical, Ltd.2005456—
+6K051681Dermillume Red, Model HR1000Care Electronics, Inc.20053—
+7K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+7K252723Dynamis Pro FamilyFotona D.O.O.20260—
+7K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+7K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+7K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+7K261964Echolaser X4Elesta S.P.A20260—