510(k) Report

Devices descending from K961279

1,498 later devices reach Sharplan Lasers, Inc. Ruby Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+6K050397Velasmooth, ShaperSyneron Medical, Ltd.2005150—
+6K050796Aurora DS, DS ApplicatorSyneron Medical, Ltd.2005301—
+6K043575Dermillume, Model PRO1000Care Electronics, Inc.20054—
+6K033072Lucentlite, Model Imd 010Industrial & Medical Design, Inc.20040—
+6K033933Powerlite 600 EX SystemPreswede AB20040—
+6K033251The Friendlylight ND: Yag LasersInnotech USA, Inc.2004519—
+6K033586Modification to Aurora DSSyneron Medical, Ltd.2003303—
+6K030186Polris LVSyneron Medical, Ltd.2003680—
+7K261975Braun Aura 7 (6041)CyDen Limited20260—
+7K261977Braun Aura 9 (6042)Cyden Limited20260—
+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—
+7K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+7K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+7K253342PICO-KSpeclipse, Inc.20251—
+7K253344Bellus-QSpeclipse, Inc.20250—
+7K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+7K250165PastelleWontech 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—
+7K250189AdvaTxAdvalight Aps20250—
+7K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+7K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) Co., Ltd.20250—
+7K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+7K241527Pastelle ProWontech Co., Ltd.20253—
+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—
+7K233473Deka LotusEl.En S.P.A.20241—
+7K240752Deka ToroEl.En S.P.A.20240—
+7K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+7K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+7K240587SmoothSkin Pure Unplugged (SSB3)Cyden Limited20240—
+7K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+7K233782SmoothSkin Pure Adapt (SSG3)Cyden Limited20232—
+7K232117Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)Wuhan Lotuxs Technology Co., Ltd.20231—
+7K232192Venus Versa PRO SystemVenus Concept, Inc.20230—
+7K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd.20230—
+7K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+7K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+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—
+7K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+7K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+7K213105Epilaser AbsoluteEpilady 2000, LLC20221—
+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—
+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—
+7K210183Waterlase iPLusBiolase, Inc.20220—
+7K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+7K213558IPL Hair Removal DeviceUlike Co., Ltd.202215—