510(k) Report

Devices descending from K910422

1,503 later devices reach Model RD-1200 Ruby Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K221679IPL Hair Remover, Model: G993, G996, G998 and G885Shenzhen Mywin Technology Co., Ltd.20220—
+7K211979Lumenis Y&R Laser SystemLumenis, Inc.20220—
+7K210183Waterlase iPLusBiolase, Inc.20220—
+7K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+7K213558IPL Hair Removal DeviceUlike Co., Ltd.202215—
+7K211639BTL-785WBTL Industries, Inc.20227—
+7K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+7K210847UltraClear Fractional Laser SystemFa International, LP20210—
+7K212907Aimanfun Lumea Comfort, A-2789/A-3588Kam Yuen Plastic Products, Ltd.202114—
+7K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+7K213041IPL Hair Removal, Model: OBT-02Glan Electronics Co., Ltd.202115—
+7K212607DarwinLuvo Medical Technologies, Inc.20210—
+7K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+7K211174IPL Hair RemovalShenzhen Qiaochengli Technology Co., Ltd.20210—
+7K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+7K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+7K203054FlexSysGme German Medical Engineering GmbH20210—
+7K203299CellFX SystemPulse Biosciences, Inc.20214—
+7K202361UltraSlim Digital, UltraSmooth DigitalWard Photonics, LLC20200—
+7K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+7K193201BTL-785FBtl20208—
+7K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+7K200746IPL Treatment SystemsShanghai Apolo Medical Technology Co., Ltd.20205—
+7K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+7K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+7K193367elysion-proHigh Technology Products S.L.U20203—
+7K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+7K191693BC-5Reveallux, Corp20190—
+7K191942MT One DiamondM&T S.R.L.20191—
+7K190319Waterlase Laser System FamilyBiolase, Inc.201919—
+7K183708Poly ClearMedtek Skincare, LLC201922—
+7K191554LightWalker Laser System FamilyFotona D.O.O.201919—
+7K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+7K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+7K182930PerioLase Nd:YAG Pulsed Dental Laser SystemMillennium Dental Technologies, Inc.20190—
+7K190938Phototherapy SystemShanghai Apolo Medical Technology Co., Ltd.201916—
+7K183260Sensilight Pro / Pistol IPLEl Global Trade, Ltd.20190—
+7K180359BTL-FR2000BTL Industries, Inc.20189—
+7K181510Echolaser X4El.En Electronic Engineering Spa20183—
+7K172273308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20185—
+7K180518GME LinScan Lite 808 Laser SystemGme German Medical Engineering GmbH20181—
+7K180900LED Light Therapy DeviceUvbiotek, LLC201829—
+7K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+7K173692D-Actor 200 Vibration Massage SystemStorz Medical AG20186—
+7K173677InMode VLazeInmode MD, Ltd.20183—
+7K173759Thermage CPT System and AccessoriesSolta Medical201821
+7K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+7K171702Exciplex308nmClarteis20175—
+7K170758Thermage FLX System and AccessoriesSolta Medical201713—
+7K170179LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer InfinityLumenis, Ltd.201714—
+7K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+7K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+7K171055Philips BlueControlPhilips Electronics Nederland B.V.20171—
+7K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+7K160312Fraxis DuoIlooda Co,., Ltd.201614—
+7K161941Pulsaderm Acne DeviceNutra Luxe MD, LLC20164—
+7K160880Photonica ProfessionalWard Photonics, LLC20166—
+7K160075Accent XLAlma Lasers, Inc.20160—
+7K161669Waterlase ExpressBiolase, Inc.201621—
+7K152737Lite TouchFocus Medical, LLC20160—
+7K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+7K160968iPulse SmoothSkin Gold Hair Removal DeviceCyden Limited2016117—
+7K153566Magma SystemFormatk Systems, Ltd.20162—
+7K160368EVO platformQuanta System Spa201636—
+7K153081Clear Bi-LightMichael Todd, LP201646—
+7K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+7K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+7K151306SoleaConvergent Dental, Inc.20151—
+7K151655CO2RE SystemSyneron Medical, Ltd.20151—
+7K150907Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner…Ellipse A/S20155—
+7K140386Lumina 24Rogers Sciences, Inc.20150—
+7K150161Venus Viva SR DeviceVenus Concept, Ltd.20159—
+7K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+7K142256Applied BioPhotonics Phototherapy System ABPT1003Applied Biophotonics, Ltd.20150—
+7K142910Legacy BXVenus Concept USA, Inc.201411—
+7K143339Mini meIluminage Ltd.(Formerly Syneron Beauty Ltd.)20140—
+7K142340Infrared Therapy SystemBeijing Huatai Healthcare Technology Co., Ltd.20140—
+7K142093V20 SystemViora, Ltd.201432—
+7K140727Cutera Picosecond Laser SystemCutera, Inc.201447—
+7K141555AdvantageLutronic Corporation201414—
+7K142376Palomar Icon Aesthetic SystemCynosure, Inc.201413—
+7K133945Cutera Picosecond Laser SystemCutera, Inc.201414—
+7K133364Picosure WorkstationCynosure, Inc.201451—
+7K131757Tattoostar Effect ComboAsclepion Laser Technologies GmbH20140—
+7K140629Venus Swan (MP)2Venus Concept, Ltd.20140—
+7K140255Stop U (Packed Black Usa); Stop U (Packed White Usa)Pollogen, Ltd.20147—
+7K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+7K133201Shaser V-Mini 2 Hair Removal SystemShaser, Inc.201496—
+7K132989Speed 808 Diode Laser SystemBeijing Toplaser Technology Co., Ltd.20140—
+7K131837CO2 Fractional LaserBeijing Honkon Technologies Co., Ltd.20140—
+7K133283Candela Gentlemax Family of Laser SystemsCandela Corp.201313—
+7K124064Young AgainEspansione Marketing S.P.A20131—
+7K131758Surgen UPollogen, Ltd.20135—
+7K131095Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa201317—
+7K130199Clarity LPC Laser SystemLutronic Corporation20135—
+7K131859Multifunctional SeriesBeijing Honkon Technologies Co., Ltd.20133—
+7K130028Resurfx 1565NM Laser ModuleLumenis, Ltd.201341—
+7K123999Illumask Acne Light Therapy MaskLa Lumiere, LLC2013112—
+7K120510TranscendSyneron Medical, Ltd.201318—
+7K130420SOLEAConvergent Dental, Inc.201321