510(k) Report

Devices descending from K924647

1,499 later devices reach DLR-1 Derma-Lase Ruby Laser/DLR-1/Derma-Lase Syst through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K213558IPL Hair Removal DeviceUlike Co., Ltd.202215—
+8K211639BTL-785WBTL Industries, Inc.20227—
+8K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+8K210847UltraClear Fractional Laser SystemFa International, LP20210—
+8K212907Aimanfun Lumea Comfort, A-2789/A-3588Kam Yuen Plastic Products, Ltd.202114—
+8K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+8K213041IPL Hair Removal, Model: OBT-02Glan Electronics Co., Ltd.202115—
+8K212607DarwinLuvo Medical Technologies, Inc.20210—
+8K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+8K211174IPL Hair RemovalShenzhen Qiaochengli Technology Co., Ltd.20210—
+8K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+8K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+8K203054FlexSysGme German Medical Engineering GmbH20210—
+8K203299CellFX SystemPulse Biosciences, Inc.20214—
+8K202361UltraSlim Digital, UltraSmooth DigitalWard Photonics, LLC20200—
+8K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+8K193201BTL-785FBtl20208—
+8K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+8K200746IPL Treatment SystemsShanghai Apolo Medical Technology Co., Ltd.20205—
+8K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+8K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+8K193367elysion-proHigh Technology Products S.L.U20203—
+8K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+8K191693BC-5Reveallux, Corp20190—
+8K191942MT One DiamondM&T S.R.L.20191—
+8K190319Waterlase Laser System FamilyBiolase, Inc.201919—
+8K183708Poly ClearMedtek Skincare, LLC201922—
+8K191554LightWalker Laser System FamilyFotona D.O.O.201919—
+8K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+8K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+8K182930PerioLase Nd:YAG Pulsed Dental Laser SystemMillennium Dental Technologies, Inc.20190—
+8K190938Phototherapy SystemShanghai Apolo Medical Technology Co., Ltd.201916—
+8K183260Sensilight Pro / Pistol IPLEl Global Trade, Ltd.20190—
+8K180359BTL-FR2000BTL Industries, Inc.20189—
+8K181510Echolaser X4El.En Electronic Engineering Spa20183—
+8K172273308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20185—
+8K180518GME LinScan Lite 808 Laser SystemGme German Medical Engineering GmbH20181—
+8K180900LED Light Therapy DeviceUvbiotek, LLC201829—
+8K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+8K173692D-Actor 200 Vibration Massage SystemStorz Medical AG20186—
+8K173677InMode VLazeInmode MD, Ltd.20183—
+8K173759Thermage CPT System and AccessoriesSolta Medical201821
+8K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+8K171702Exciplex308nmClarteis20175—
+8K170758Thermage FLX System and AccessoriesSolta Medical201713—
+8K170179LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer InfinityLumenis, Ltd.201714—
+8K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+8K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+8K171055Philips BlueControlPhilips Electronics Nederland B.V.20171—
+8K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+8K160312Fraxis DuoIlooda Co,., Ltd.201614—
+8K161941Pulsaderm Acne DeviceNutra Luxe MD, LLC20164—
+8K160880Photonica ProfessionalWard Photonics, LLC20166—
+8K160075Accent XLAlma Lasers, Inc.20160—
+8K161669Waterlase ExpressBiolase, Inc.201621—
+8K152737Lite TouchFocus Medical, LLC20160—
+8K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+8K160968iPulse SmoothSkin Gold Hair Removal DeviceCyden Limited2016117—
+8K153566Magma SystemFormatk Systems, Ltd.20162—
+8K160368EVO platformQuanta System Spa201636—
+8K153081Clear Bi-LightMichael Todd, LP201646—
+8K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+8K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+8K151306SoleaConvergent Dental, Inc.20151—
+8K151655CO2RE SystemSyneron Medical, Ltd.20151—
+8K150907Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner…Ellipse A/S20155—
+8K140386Lumina 24Rogers Sciences, Inc.20150—
+8K150161Venus Viva SR DeviceVenus Concept, Ltd.20159—
+8K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+8K142256Applied BioPhotonics Phototherapy System ABPT1003Applied Biophotonics, Ltd.20150—
+8K142910Legacy BXVenus Concept USA, Inc.201411—
+8K143339Mini meIluminage Ltd.(Formerly Syneron Beauty Ltd.)20140—
+8K142340Infrared Therapy SystemBeijing Huatai Healthcare Technology Co., Ltd.20140—
+8K142093V20 SystemViora, Ltd.201432—
+8K140727Cutera Picosecond Laser SystemCutera, Inc.201447—
+8K141555AdvantageLutronic Corporation201414—
+8K142376Palomar Icon Aesthetic SystemCynosure, Inc.201413—
+8K133945Cutera Picosecond Laser SystemCutera, Inc.201414—
+8K133364Picosure WorkstationCynosure, Inc.201451—
+8K131757Tattoostar Effect ComboAsclepion Laser Technologies GmbH20140—
+8K140629Venus Swan (MP)2Venus Concept, Ltd.20140—
+8K140255Stop U (Packed Black Usa); Stop U (Packed White Usa)Pollogen, Ltd.20147—
+8K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+8K133201Shaser V-Mini 2 Hair Removal SystemShaser, Inc.201496—
+8K132989Speed 808 Diode Laser SystemBeijing Toplaser Technology Co., Ltd.20140—
+8K131837CO2 Fractional LaserBeijing Honkon Technologies Co., Ltd.20140—
+8K133283Candela Gentlemax Family of Laser SystemsCandela Corp.201313—
+8K124064Young AgainEspansione Marketing S.P.A20131—
+8K131758Surgen UPollogen, Ltd.20135—
+8K131095Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa201317—
+8K130199Clarity LPC Laser SystemLutronic Corporation20135—
+8K131859Multifunctional SeriesBeijing Honkon Technologies Co., Ltd.20133—
+8K130028Resurfx 1565NM Laser ModuleLumenis, Ltd.201341—
+8K123999Illumask Acne Light Therapy MaskLa Lumiere, LLC2013112—
+8K120510TranscendSyneron Medical, Ltd.201318—
+8K130420SOLEAConvergent Dental, Inc.201321
+8K130193Fraxel Dual 1550/1927 Laser SystemSolta Medical, Inc.201325—
+8K122493GenesisplusCutera, Inc.201318—
+8K123971Cynosure 1064NM Diode LaserCynosure, Inc.201325—
+8K123573Youlaser CO2 LaserQuanta System Spa201319—