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
+6K090399Trios SystemViora, Ltd.20090—
+6K083590Iskra Medical Green Irf PrestigeIskra Medical, D.O.O.200913—
+6K083595EzlaseBiolase Technology, Inc.200958—
+6K083900Erbium Fractional HandpiecePalomar Medical Products, Inc.2009158—
+6K081307Omnilux Clear-UPhoto Therapeutics, Inc.2009169—
+6K082622Alma Lasers Accent B-Shape Massager Handpiece/ModuleAlma Lasers, Ltd.200945—
+6K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+6K082247Evis MD Platinum Red Light TherapyAgeless Beauty Corporation20081—
+6K073000LumaprobeClareblend, Inc.20080—
+6K073022Clareblend Led Probes Model# 7201-415, 7204-631, 7205-830Clareblend, Inc.20080—
+6K080638CLAROClrs Technology Corporation20082—
+6K080496Mosaic ECO2 Laser SystemLutronic Corporation200830—
+6K080915Fraxel RE:Pair (Fraxel Iii SR) Laser System and AccessoriesReliant Technologies, Inc.2008187—
+6K081219Apollo Mini Ipl SystemSandstone Medical Technologies, LLC20083—
+6K080959Dornier Medilas D 30 Laser, Medilas D 1064Dornier Medtech America, Inc.20084—
+6K080244Palomar Lux 1540 HandpiecePalomar Medical Products, Inc.2008161—
+6K081324Candela Family of Q-Switched Alexandrite LasersCandela Corp.2008112—
+6K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+6K080374Biosyag Medical SystemBios S.R.L.20082—
+6K073477Photonova Family of Pulsed Light SystemsPhotonova Ofsweden AB20083—
+6K073534Candela Family of Q-Switched Alexandrite Laser (Alexlazr) SystemsCandela Corp.2008113—
+6K072459Omnilux New-UPhoto Therapeutics, Inc.200891—
+6K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc.2008202—
+6K072331Radiancy Mistral DeviceRadiancy (Israel), Ltd.20086—
+6K072699Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models: Accent, Accent XLAlma Lasers, Ltd.200784—
+6K070296Visiolite Ophthalmic ER: Yag Laser SystemAce Vision Group20070—
+6K070392Mosaic Laser SystemLutronic Corporation20078—
+6K071152Palomar Erbium HandpiecePalomar Medical Products, Inc.2007159—
+6K070284Fralex SR 1500 Laser System (Fralex II SR Laser System)Reliant Technologies, Inc.2007172—
+6K063808Fraxel IV SR Laser SystemReliant Technologies, Inc.200734—
+6K063867Cutera ER:Ysgg Laser HandpieceCutera, Inc.20072—
+6K070138Cutera ER:Yag Laser HandpieceCutera, Inc.20071—
+6K061652Palomar LUX1540 HandpiecePalomar Medical Products, Inc.2007259—
+6K063800Candela Fluorescent Pulsed Light SystemCandela Corp.20070—
+6K062303Fraxel II SR Laser SystemReliant Technologies, Inc.2007226—
+6K060792IllumimedPhotoactif, LLC2006115—
+6K062589Serenity PSF (Pneumatic Skin Flattening) SystemInolase 2002, Ltd.20063—
+6K062312Axiom Pulsed Light SystemGeneral Project S.R.L.20060—
+6K062048Aesthera Photopneumatic (PPX) SystemAesthera Corporation20064—
+6K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are…Intermedic Arfran, SA2006299—
+6K061117Nanolite Skin Care SystemNanolite Technology, Inc.20060—
+6K060407Juniper Cooling DeviceJuniper Medical Technology, Inc.200636—
+6K060977Medlite C Series Compression Tool and Handpiece Attachment Accessory, Model 659-0523Hoya Conbio, Inc.20060—
+6K060567Spectragenics Ats-1Spectragenics, Inc.20062—
+6K053047Fraxel SR Laser SystemReliant Technologies, Inc.2006205—
+6K060216Energist Ultra VPL Intense Pulse Light SystemEnergist, Ltd.20060—
+6K060234Mccue Energist Ultra VPL Intense Pulse Light SystemMccue Plc20068—
+6K052442Radiancy Skinstation with Psoriasis Light Unit AssemblyRadiancy (Israel), Ltd.200612—
+6K051259Versaclear Skin Therapy System, Model 100Theralight, Inc.200547—
+6K050216Omnilux Revive and Omnilux PlusPhoto Therapeutics Limited2005160—
+6K043032Dealight IplEuropro, Inc.20050—
+6K051255Lumiphase-ROpusmed, Inc.2005143—
+6K050673Candela Family of Pulse Dye Laser SystemsCandela Corp.20051332
+6K050397Velasmooth, ShaperSyneron Medical, Ltd.2005150—
+6K050796Aurora DS, DS ApplicatorSyneron Medical, Ltd.2005301—
+6K043575Dermillume, Model PRO1000Care Electronics, Inc.20054—
+6K033933Powerlite 600 EX SystemPreswede AB20040—
+6K033586Modification to Aurora DSSyneron Medical, Ltd.2003303—
+6K030186Polris LVSyneron Medical, Ltd.2003680—
+7K261975Braun Aura 7 (6041)CyDen Limited20260—
+7K261977Braun Aura 9 (6042)Cyden Limited20260—
+7K260715CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd.20260—
+7K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+7K253765Vanish ProDdc Technologies, Inc.20260—
+7K260153Q-Switched Nd: YAG Laser System (Glamor Q)Nanjing Bestview Laser S&T Co., Ltd.20260—
+7K260511Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20260—
+7K254047Hair Removal Device (CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12 Pro, CTU05, CTU07…Shenzhen Chuangtong Yigou Technology Co., Ltd.20260—
+7K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+7K253666IPL Hair Removal Device (Models: T31A, T32A)Shenzhen Mlay Intelligent Technology Co., Ltd.20260—
+7K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+7K253342PICO-KSpeclipse, Inc.20251—
+7K253054LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.20250—
+7K253344Bellus-QSpeclipse, Inc.20250—
+7K252618IPL Hair Removal Device (I6 S1, I6 D1, I6 M1)Alovea Healthcare Co., Ltd.20250—
+7K252272ORA Method LED Gua Sha (GS-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+7K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+7K251727GLAM LED Facial Mask (TB-2386F)Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.20250—
+7K251588LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910)Shenzhen Fittop Health Technology Co., Ltd.20252—
+7K251076Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)Shenzhen Lifotronic Technology Co., Ltd.20250—
+7K250761KALA Therapy Wand (Model: KALA-03)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+7K250165PastelleWontech Co., Ltd.20250—
+7K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—
+7K251632Optimas MAX SystemInMode, Ltd.20251—
+7K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+7K250722Nd: YAG Laser Therapy System (QN-1)Hebei JT Medical Co., Ltd.20250—
+7K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+7K250809Stellar M22Lumenis Be, Ltd.20250—
+7K242151Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B)Shenzhen Nuon Medical Equipment Co., Ltd.20251—
+7K250189AdvaTxAdvalight Aps20250—
+7K243630Medical Laser System Incanto / Evoline Platinum /EvolineSolar LS Cjsc20250—
+7K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+7K250171IPL Hair Removal Device (BE965A, BE965B, BE965C)Shenzhen Yang WO Electronic Co., Ltd.20251—
+7K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+7K241527Pastelle ProWontech Co., Ltd.20253—
+7K242977308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D…Xuzhou Kernel Medical Equipment Co., Ltd.20250—
+7K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+7K243362SmoothSkin Pure Switch (SSC1)Cyden Limited20241—
+7K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+7K233473Deka LotusEl.En S.P.A.20241—
+7K240752Deka ToroEl.En S.P.A.20240—