510(k) Report

Devices descending from K955612

1,548 later devices reach RD-1200H Normal Mode Ruby Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+7K240587SmoothSkin Pure Unplugged (SSB3)Cyden Limited20240—
+7K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+7K231910DermRays ReviveWuhan Lotuxs Technology Co., Ltd.20240—
+7K233782SmoothSkin Pure Adapt (SSG3)Cyden Limited20232—
+7K232236EchoQuanta System Spa20230—
+7K232192Venus Versa PRO SystemVenus Concept, Inc.20230—
+7K222790F65 Laser SystemLumenis Be, Ltd.20233—
+7K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+7K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+7K230990Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)Candela Corporation20230—
+7K222556BTL-785XBTL Industries, Inc.20235—
+7K230107Aimanfun Lumea Comfort, Model: A-2788, A-2789 and A-3588Kam Yuen Plastic Products, Ltd.20230—
+7K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+7K222221Deka HelixEl.En Electronic Engineering Spa20231—
+7K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+7K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+7K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+7K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+7K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+7K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+7K221214Hand-held IPL device (IPL Home Use Hair Removal Device) Model:FZ-608, FZ-608G, FZ-100…Shenzhen Ionka Medical Technology Co., Ltd.202212—
+7K213267Dynamis Pro FamilyFotona D.O.O.20222—
+7K221635IPL sapphire ice cooling hair remove deviceShenzhen Desida Technology Co., Ltd.20220—
+7K221679IPL Hair Remover, Model: G993, G996, G998 and G885Shenzhen Mywin Technology Co., Ltd.20220—
+7K211979Lumenis Y&R Laser SystemLumenis, Inc.20220—
+7K213261EpilMENeauvia North America20220—
+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—
+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—
+7K200525Medical Diode Laser Hair Removal SystemWeifang Mingliang Electronics Co., Ltd.20201—
+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—
+7K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+7K193367elysion-proHigh Technology Products S.L.U20203—
+7K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+7K192569Diode Laser Therapy SystemSan HE Lefis Electronics Co., Ltd.20191—
+7K192516Diode Laser 808nmBeijing Superlaser Technology Co., Ltd.20191—
+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—
+7K182930PerioLase Nd:YAG Pulsed Dental Laser SystemMillennium Dental Technologies, Inc.20190—
+7K190938Phototherapy SystemShanghai Apolo Medical Technology Co., Ltd.201916—
+7K183566CLARITY II Laser SystemLutronic Corporation201911
+7K183260Sensilight Pro / Pistol IPLEl Global Trade, Ltd.20190—
+7K180359BTL-FR2000BTL Industries, Inc.20189—
+7K182663Nobleen Long Pulsed Alexandrite & Nd: YAG Laser SystemFinemec Co., Ltd.20180—
+7K181510Echolaser X4El.En Electronic Engineering Spa20183—
+7K180900LED Light Therapy DeviceUvbiotek, LLC201829—
+7K173700PICOPLUS Laser SystemLutronic Corporation20187—
+7K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+7K180593Vbeam Prima Laser SystemSyneron-Candela20182—
+7K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+7K173692D-Actor 200 Vibration Massage SystemStorz Medical AG20186—
+7K173759Thermage CPT System and AccessoriesSolta Medical201821
+7K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+7K170758Thermage FLX System and AccessoriesSolta Medical201713—
+7K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+7K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+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—
+7K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+7K160075Accent XLAlma Lasers, Inc.20160—
+7K161669Waterlase ExpressBiolase, Inc.201621—
+7K152737Lite TouchFocus Medical, LLC20160—
+7K160227ACCENTO / HWA Dual/Single laserBison Medical Co, Ltd.20160—
+7K160968iPulse SmoothSkin Gold Hair Removal DeviceCyden Limited2016117—
+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—
+7K140386Lumina 24Rogers Sciences, Inc.20150—
+7K150161Venus Viva SR DeviceVenus Concept, Ltd.20159—
+7K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa201516—
+7K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+7K142256Applied BioPhotonics Phototherapy System ABPT1003Applied Biophotonics, Ltd.20150—