510(k) Report

Devices descending from K960032

1,152 later devices reach Coherent Versapulse Aesthetic Surgical Lasers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K072331Radiancy Mistral DeviceRadiancy (Israel), Ltd.20086—
+3K072344Apl Medical SystemBios S.R.L.20076—
+3K071469Inolase Serenity PSF ( Pneumatic Skin Flattening) SystemCandela Corp.20071—
+3K063427Lumina Intense Pulsed Light (& Laser) SystemLynton Lasers Limited20070—
+3K070388Profile Multi-Platform SystemSciton, Inc2007129—
+3K070138Cutera ER:Yag Laser HandpieceCutera, Inc.20071—
+3K063867Cutera ER:Ysgg Laser HandpieceCutera, Inc.20072—
+3K063571Palomar LUX2940 HandpiecePalomar Medical Technologies, Inc.2007160—
+3K063800Candela Fluorescent Pulsed Light SystemCandela Corp.20070—
+3K060792IllumimedPhotoactif, LLC2006115—
+3K063060Blueshine Light Shine Systems, SP, Twin and Compact SPBlueshine Srl20060—
+3K062312Axiom Pulsed Light SystemGeneral Project S.R.L.20060—
+3K062048Aesthera Photopneumatic (PPX) SystemAesthera Corporation20064—
+3K052354Oculase MDBiolase Technology, Inc.20065—
+3K061117Nanolite Skin Care SystemNanolite Technology, Inc.20060—
+3K060516Ellipse 12PL, Model 9ESL7228Danish Dermatologic Development A/S200612—
+3K052371Depilite EL-8B Series Dermo Flash SystemsHair International Systems USA, Inc.20060—
+3K060567Spectragenics Ats-1Spectragenics, Inc.20062—
+3K060216Energist Ultra VPL Intense Pulse Light SystemEnergist, Ltd.20060—
+3K060234Mccue Energist Ultra VPL Intense Pulse Light SystemMccue Plc20068—
+3K052991Radiancy Facial Skincare DeviceRadiancy (Israel), Ltd.20060—
+3K052688Ellipse Flex PPT, Model 9ESF7255Danish Dermatologic Development A/S200523—
+3K051259Versaclear Skin Therapy System, Model 100Theralight, Inc.200547—
+3K050216Omnilux Revive and Omnilux PlusPhoto Therapeutics Limited2005160—
+3K043032Dealight IplEuropro, Inc.20050—
+3K051359Candela Family of Pulsed Dye Laser Systems: Pigmented Lesion Handpiece AccessoryCandela Corp.200511
+3K050841Fraxel SR Laser SystemReliant Technologies, Inc.2005238—
+3K051255Lumiphase-ROpusmed, Inc.2005143—
+3K042630Revlight Skin Care SystemSkincare Technology, Inc.2005402—
+3K050047Cutera Optional Pulsed Light Hand Piece FamilyCutera, Inc.2005109—
+3K043575Dermillume, Model PRO1000Care Electronics, Inc.20054—
+3K033946Lovely SystemMsq (M2), Ltd.2004737—
+3K040156Ifl Professional System, Model C100Cyden Limited20040—
+3K033933Powerlite 600 EX SystemPreswede AB20040—
+3K014253Dermachiller 4Paradigm Trex, LLC200250—
+3K013748Candela Sclero Long Pulse Laser (Aka Vbeam)Candela Corp.2002699—
+4K252561BTL-754FFBTL Industries, Inc.20260—
+4K250776Lithoblast Single Use Holmium Laser FibersDawell Medical, LLC20250—
+4K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) Co., Ltd.20250—
+4K231948MediyagMedicreations, LLC20240—
+4K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+4K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+4K233473Deka LotusEl.En S.P.A.20241—
+4K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC20240—
+4K234057NirvanaEl.En S.P.A.20240—
+4K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+4K232106Air Gap FiberWontech Co., Ltd.20240—
+4K221766SolonLmg Lasers Comercio, Importacao E Exportacao Ltda20240—
+4K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+4K232716Q-Switched Nd:Yag laserHebei Zhemai Technology Co., Ltd.20231—
+4K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd.20230—
+4K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+4K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+4K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+4K22079410PLTentech Co., Ltd.20220—
+4K212790XLase PlusBiotec Italia, Srl20220—
+4K221571InMode Multi-systemInMode, Ltd.20222—
+4K220189LISA Laser Surgical FibersOmni-Guide Holdings, Inc.20225—
+4K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+4K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+4K202288FinebeamSNJ Co., Ltd.20212—
+4K203728DarwinLuvo Medical Technologies, Inc.20211—
+4K201171LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe DisposableLeoni Fiber Optics, Inc.20210—
+4K203054FlexSysGme German Medical Engineering GmbH20210—
+4K202361UltraSlim Digital, UltraSmooth DigitalWard Photonics, LLC20200—
+4K202172StarWalkerFotona D.O.O.20203—
+4K200616E>EyeCE-Swin20200—
+4K200746IPL Treatment SystemsShanghai Apolo Medical Technology Co., Ltd.20205—
+4K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+4K193656SkyPulseFotona D.O.O.202011—
+4K200234Surgical laser fibersQuanta System Spa20202—
+4K191693BC-5Reveallux, Corp20190—
+4K183708Poly ClearMedtek Skincare, LLC201922—
+4K190938Phototherapy SystemShanghai Apolo Medical Technology Co., Ltd.201916—
+4K180900LED Light Therapy DeviceUvbiotek, LLC201829—
+4K180508Joule SystemSciton, Inc20183—
+4K173285Joule SystemSciton, Inc20185—
+4K172413MT ONEM&T S.R.L.20175—
+4K171227StarWalkerFotona D.O.O.20177—
+4K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+4K171055Philips BlueControlPhilips Electronics Nederland B.V.20171—
+4K163196ACTION II Laser SystemLutronic Corporation20170—
+4K161941Pulsaderm Acne DeviceNutra Luxe MD, LLC20164—
+4K160880Photonica ProfessionalWard Photonics, LLC20166—
+4K151855SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral…Surgical Laser Incorporated20160—
+4K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+4K153566Magma SystemFormatk Systems, Ltd.20162—
+4K153717Venus Versa SystemVenus Concept, Ltd.20161—
+4K151337StrialiteCentre Light Solutions, LLC20160—
+4K153081Clear Bi-LightMichael Todd, LP201646—
+4K152790Venus Versa SystemVenus Concept, Ltd.20160—
+4K152714Quanta ForteQuanta System Spa201513—
+4K152012EVO platformQuanta System Spa201537—
+4K152417Adler MicroMed Laser Surgery FibersAdler Micromed, Inc.20153—
+4K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+4K150907Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner…Ellipse A/S20155—
+4K140386Lumina 24Rogers Sciences, Inc.20150—
+4K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+4K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+4K142256Applied BioPhotonics Phototherapy System ABPT1003Applied Biophotonics, Ltd.20150—