510(k) Report

Devices descending from K962109

1,499 later devices reach SLS Chromos 694 QD Ruby Laser to BE Renamed Mehl QD Ruby Laser System for Hair… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K213558IPL Hair Removal DeviceUlike Co., Ltd.202215—
+6K211639BTL-785WBTL Industries, Inc.20227—
+6K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+6K210847UltraClear Fractional Laser SystemFa International, LP20210—
+6K212907Aimanfun Lumea Comfort, A-2789/A-3588Kam Yuen Plastic Products, Ltd.202114—
+6K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+6K213041IPL Hair Removal, Model: OBT-02Glan Electronics Co., Ltd.202115—
+6K212607DarwinLuvo Medical Technologies, Inc.20210—
+6K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+6K211174IPL Hair RemovalShenzhen Qiaochengli Technology Co., Ltd.20210—
+6K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+6K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+6K203054FlexSysGme German Medical Engineering GmbH20210—
+6K203299CellFX SystemPulse Biosciences, Inc.20214—
+6K202361UltraSlim Digital, UltraSmooth DigitalWard Photonics, LLC20200—
+6K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+6K193201BTL-785FBtl20208—
+6K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+6K200746IPL Treatment SystemsShanghai Apolo Medical Technology Co., Ltd.20205—
+6K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+6K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+6K193367elysion-proHigh Technology Products S.L.U20203—
+6K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+6K191693BC-5Reveallux, Corp20190—
+6K191942MT One DiamondM&T S.R.L.20191—
+6K190319Waterlase Laser System FamilyBiolase, Inc.201919—
+6K183708Poly ClearMedtek Skincare, LLC201922—
+6K191554LightWalker Laser System FamilyFotona D.O.O.201919—
+6K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+6K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+6K182930PerioLase Nd:YAG Pulsed Dental Laser SystemMillennium Dental Technologies, Inc.20190—
+6K190938Phototherapy SystemShanghai Apolo Medical Technology Co., Ltd.201916—
+6K183260Sensilight Pro / Pistol IPLEl Global Trade, Ltd.20190—
+6K180359BTL-FR2000BTL Industries, Inc.20189—
+6K181510Echolaser X4El.En Electronic Engineering Spa20183—
+6K172273308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20185—
+6K180518GME LinScan Lite 808 Laser SystemGme German Medical Engineering GmbH20181—
+6K180900LED Light Therapy DeviceUvbiotek, LLC201829—
+6K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+6K173692D-Actor 200 Vibration Massage SystemStorz Medical AG20186—
+6K173677InMode VLazeInmode MD, Ltd.20183—
+6K173759Thermage CPT System and AccessoriesSolta Medical201821
+6K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+6K171702Exciplex308nmClarteis20175—
+6K170758Thermage FLX System and AccessoriesSolta Medical201713—
+6K170179LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer InfinityLumenis, Ltd.201714—
+6K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+6K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+6K171055Philips BlueControlPhilips Electronics Nederland B.V.20171—
+6K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+6K160312Fraxis DuoIlooda Co,., Ltd.201614—
+6K161941Pulsaderm Acne DeviceNutra Luxe MD, LLC20164—
+6K160880Photonica ProfessionalWard Photonics, LLC20166—
+6K160075Accent XLAlma Lasers, Inc.20160—
+6K161669Waterlase ExpressBiolase, Inc.201621—
+6K152737Lite TouchFocus Medical, LLC20160—
+6K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+6K160968iPulse SmoothSkin Gold Hair Removal DeviceCyden Limited2016117—
+6K153566Magma SystemFormatk Systems, Ltd.20162—
+6K160368EVO platformQuanta System Spa201636—
+6K153081Clear Bi-LightMichael Todd, LP201646—
+6K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+6K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+6K151306SoleaConvergent Dental, Inc.20151—
+6K151655CO2RE SystemSyneron Medical, Ltd.20151—
+6K150907Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner…Ellipse A/S20155—
+6K140386Lumina 24Rogers Sciences, Inc.20150—
+6K150161Venus Viva SR DeviceVenus Concept, Ltd.20159—
+6K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+6K142256Applied BioPhotonics Phototherapy System ABPT1003Applied Biophotonics, Ltd.20150—
+6K142910Legacy BXVenus Concept USA, Inc.201411—
+6K143339Mini meIluminage Ltd.(Formerly Syneron Beauty Ltd.)20140—
+6K142340Infrared Therapy SystemBeijing Huatai Healthcare Technology Co., Ltd.20140—
+6K142093V20 SystemViora, Ltd.201432—
+6K140727Cutera Picosecond Laser SystemCutera, Inc.201447—
+6K141555AdvantageLutronic Corporation201414—
+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—
+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—
+6K133283Candela Gentlemax Family of Laser SystemsCandela Corp.201313—
+6K124064Young AgainEspansione Marketing S.P.A20131—
+6K131758Surgen UPollogen, Ltd.20135—
+6K131095Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa201317—
+6K130199Clarity LPC Laser SystemLutronic Corporation20135—
+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—
+6K122493GenesisplusCutera, Inc.201318—
+6K123971Cynosure 1064NM Diode LaserCynosure, Inc.201325—
+6K123573Youlaser CO2 LaserQuanta System Spa201319—