510(k) Report

Devices descending from K962109

1,499 later devices reach SLS Chromos 694 QD Ruby Laser to BE Renamed Mehl QD Ruby Laser System for Hair… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K080496Mosaic ECO2 Laser SystemLutronic Corporation200830—
+5K080915Fraxel RE:Pair (Fraxel Iii SR) Laser System and AccessoriesReliant Technologies, Inc.2008187—
+5K081219Apollo Mini Ipl SystemSandstone Medical Technologies, LLC20083—
+5K080959Dornier Medilas D 30 Laser, Medilas D 1064Dornier Medtech America, Inc.20084—
+5K080244Palomar Lux 1540 HandpiecePalomar Medical Products, Inc.2008161—
+5K081324Candela Family of Q-Switched Alexandrite LasersCandela Corp.2008112—
+5K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+5K080374Biosyag Medical SystemBios S.R.L.20082—
+5K073477Photonova Family of Pulsed Light SystemsPhotonova Ofsweden AB20083—
+5K073534Candela Family of Q-Switched Alexandrite Laser (Alexlazr) SystemsCandela Corp.2008113—
+5K072459Omnilux New-UPhoto Therapeutics, Inc.200891—
+5K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc.2008202—
+5K072331Radiancy Mistral DeviceRadiancy (Israel), Ltd.20086—
+5K072699Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models: Accent, Accent XLAlma Lasers, Ltd.200784—
+5K070296Visiolite Ophthalmic ER: Yag Laser SystemAce Vision Group20070—
+5K070392Mosaic Laser SystemLutronic Corporation20078—
+5K071152Palomar Erbium HandpiecePalomar Medical Products, Inc.2007159—
+5K070284Fralex SR 1500 Laser System (Fralex II SR Laser System)Reliant Technologies, Inc.2007172—
+5K063808Fraxel IV SR Laser SystemReliant Technologies, Inc.200734—
+5K063867Cutera ER:Ysgg Laser HandpieceCutera, Inc.20072—
+5K070138Cutera ER:Yag Laser HandpieceCutera, Inc.20071—
+5K061652Palomar LUX1540 HandpiecePalomar Medical Products, Inc.2007259—
+5K063800Candela Fluorescent Pulsed Light SystemCandela Corp.20070—
+5K062303Fraxel II SR Laser SystemReliant Technologies, Inc.2007226—
+5K060792IllumimedPhotoactif, LLC2006115—
+5K062589Serenity PSF (Pneumatic Skin Flattening) SystemInolase 2002, Ltd.20063—
+5K062312Axiom Pulsed Light SystemGeneral Project S.R.L.20060—
+5K062048Aesthera Photopneumatic (PPX) SystemAesthera Corporation20064—
+5K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are…Intermedic Arfran, SA2006299—
+5K061117Nanolite Skin Care SystemNanolite Technology, Inc.20060—
+5K060407Juniper Cooling DeviceJuniper Medical Technology, Inc.200636—
+5K060977Medlite C Series Compression Tool and Handpiece Attachment Accessory, Model 659-0523Hoya Conbio, Inc.20060—
+5K060567Spectragenics Ats-1Spectragenics, Inc.20062—
+5K053047Fraxel SR Laser SystemReliant Technologies, Inc.2006205—
+5K060216Energist Ultra VPL Intense Pulse Light SystemEnergist, Ltd.20060—
+5K060234Mccue Energist Ultra VPL Intense Pulse Light SystemMccue Plc20068—
+5K052442Radiancy Skinstation with Psoriasis Light Unit AssemblyRadiancy (Israel), Ltd.200612—
+5K051259Versaclear Skin Therapy System, Model 100Theralight, Inc.200547—
+5K050216Omnilux Revive and Omnilux PlusPhoto Therapeutics Limited2005160—
+5K043032Dealight IplEuropro, Inc.20050—
+5K051255Lumiphase-ROpusmed, Inc.2005143—
+5K050397Velasmooth, ShaperSyneron Medical, Ltd.2005150—
+5K050796Aurora DS, DS ApplicatorSyneron Medical, Ltd.2005301—
+5K043575Dermillume, Model PRO1000Care Electronics, Inc.20054—
+5K033072Lucentlite, Model Imd 010Industrial & Medical Design, Inc.20040—
+5K033933Powerlite 600 EX SystemPreswede AB20040—
+5K033251The Friendlylight ND: Yag LasersInnotech USA, Inc.2004519—
+5K033586Modification to Aurora DSSyneron Medical, Ltd.2003303—
+5K030186Polris LVSyneron Medical, Ltd.2003680—
+6K261975Braun Aura 7 (6041)CyDen Limited20260—
+6K261977Braun Aura 9 (6042)Cyden Limited20260—
+6K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+6K253765Vanish ProDdc Technologies, Inc.20260—
+6K260153Q-Switched Nd: YAG Laser System (Glamor Q)Nanjing Bestview Laser S&T Co., Ltd.20260—
+6K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+6K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+6K253342PICO-KSpeclipse, Inc.20251—
+6K253344Bellus-QSpeclipse, Inc.20250—
+6K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+6K250165PastelleWontech Co., Ltd.20250—
+6K251632Optimas MAX SystemInMode, Ltd.20251—
+6K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+6K250722Nd: YAG Laser Therapy System (QN-1)Hebei JT Medical Co., Ltd.20250—
+6K250189AdvaTxAdvalight Aps20250—
+6K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+6K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) Co., Ltd.20250—
+6K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+6K241527Pastelle ProWontech Co., Ltd.20253—
+6K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+6K243362SmoothSkin Pure Switch (SSC1)Cyden Limited20241—
+6K233473Deka LotusEl.En S.P.A.20241—
+6K240752Deka ToroEl.En S.P.A.20240—
+6K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+6K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+6K240587SmoothSkin Pure Unplugged (SSB3)Cyden Limited20240—
+6K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+6K233782SmoothSkin Pure Adapt (SSG3)Cyden Limited20232—
+6K232117Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)Wuhan Lotuxs Technology Co., Ltd.20231—
+6K232192Venus Versa PRO SystemVenus Concept, Inc.20230—
+6K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd.20230—
+6K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+6K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+6K222556BTL-785XBTL Industries, Inc.20235—
+6K230107Aimanfun Lumea Comfort, Model: A-2788, A-2789 and A-3588Kam Yuen Plastic Products, Ltd.20230—
+6K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+6K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+6K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+6K213105Epilaser AbsoluteEpilady 2000, LLC20221—
+6K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+6K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+6K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+6K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+6K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+6K221214Hand-held IPL device (IPL Home Use Hair Removal Device) Model:FZ-608, FZ-608G, FZ-100…Shenzhen Ionka Medical Technology Co., Ltd.202212—
+6K213267Dynamis Pro FamilyFotona D.O.O.20222—
+6K221635IPL sapphire ice cooling hair remove deviceShenzhen Desida Technology Co., Ltd.20220—
+6K221679IPL Hair Remover, Model: G993, G996, G998 and G885Shenzhen Mywin Technology Co., Ltd.20220—
+6K211979Lumenis Y&R Laser SystemLumenis, Inc.20220—
+6K210183Waterlase iPLusBiolase, Inc.20220—
+6K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—