510(k) Report

Devices descending from K980537

1,242 later devices reach ND: Yag Accessory for Photoderm System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K070004AccentAlma Lasers, Ltd.2007181—
+3K063800Candela Fluorescent Pulsed Light SystemCandela Corp.20070—
+3K063828Diomed Delta 25Diomed, Ltd.20075—
+3K060792IllumimedPhotoactif, LLC2006115—
+3K063060Blueshine Light Shine Systems, SP, Twin and Compact SPBlueshine Srl20060—
+3K062369Iridex Oculight TXIridex Corp200673—
+3K062312Axiom Pulsed Light SystemGeneral Project S.R.L.20060—
+3K062048Aesthera Photopneumatic (PPX) SystemAesthera Corporation20064—
+3K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are…Intermedic Arfran, SA2006299—
+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—
+3K053616Polaris WR, ST ApplicatorSyneron Medical, Ltd.2006133—
+3K060033Profile Multi-Platform SystemSciton, Inc2006221—
+3K052991Radiancy Facial Skincare DeviceRadiancy (Israel), Ltd.20060—
+3K052688Ellipse Flex PPT, Model 9ESF7255Danish Dermatologic Development A/S200523—
+3K051214Aluma Skin Renewal SystemLumenis, Inc.2005476—
+3K051259Versaclear Skin Therapy System, Model 100Theralight, Inc.200547—
+3K051876Multiwave XRPacific Quantum Instruments, Inc.20050—
+3K050216Omnilux Revive and Omnilux PlusPhoto Therapeutics Limited2005160—
+3K043032Dealight IplEuropro, Inc.20050—
+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—
+3K050293Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP Plus ND: Yag Family of…Fotona D.D.2005200—
+3K043575Dermillume, Model PRO1000Care Electronics, Inc.20054—
+3K041959Polaris DS/CometSyneron Medical, Ltd.2004301—
+3K040384Mydon CWavelight Laser Technologie AG200451—
+3K033946Lovely SystemMsq (M2), Ltd.2004737—
+3K033072Lucentlite, Model Imd 010Industrial & Medical Design, Inc.20040—
+3K040156Ifl Professional System, Model C100Cyden Limited20040—
+3K033933Powerlite 600 EX SystemPreswede AB20040—
+3K033251The Friendlylight ND: Yag LasersInnotech USA, Inc.2004519—
+3K033172Candela Gentleyag Family of Laser SystemsCandela Corp.2003654—
+3K013748Candela Sclero Long Pulse Laser (Aka Vbeam)Candela Corp.2002699—
+4K252561BTL-754FFBTL Industries, Inc.20260—
+4K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+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—
+4K234057NirvanaEl.En S.P.A.20240—
+4K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+4K221766SolonLmg Lasers Comercio, Importacao E Exportacao Ltda20240—
+4K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+4K232716Q-Switched Nd:Yag laserHebei Zhemai Technology Co., Ltd.20231—
+4K232117Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)Wuhan Lotuxs Technology Co., Ltd.20231—
+4K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd.20230—
+4K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+4K22079410PLTentech Co., Ltd.20220—
+4K212790XLase PlusBiotec Italia, Srl20220—
+4K213761Joule diVa SystemSciton, Inc20220—
+4K221571InMode Multi-systemInMode, Ltd.20222—
+4K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+4K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+4K202288FinebeamSNJ Co., Ltd.20212—
+4K203728DarwinLuvo Medical Technologies, Inc.20211—
+4K203054FlexSysGme German Medical Engineering GmbH20210—
+4K202361UltraSlim Digital, UltraSmooth DigitalWard Photonics, LLC20200—
+4K202172StarWalkerFotona D.O.O.20203—
+4K192621Medical RFTriworks Group Srl20200—
+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—
+4K191693BC-5Reveallux, Corp20190—
+4K183708Poly ClearMedtek Skincare, LLC201922—
+4K190938Phototherapy SystemShanghai Apolo Medical Technology Co., Ltd.201916—
+4K180900LED Light Therapy DeviceUvbiotek, LLC201829—
+4K180508Joule SystemSciton, Inc20183—
+4K173677InMode VLazeInmode MD, Ltd.20183—
+4K173285Joule SystemSciton, Inc20185—
+4K172413MT ONEM&T S.R.L.20175—
+4K170179LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer InfinityLumenis, Ltd.201714—
+4K171227StarWalkerFotona D.O.O.20177—
+4K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+4K171055Philips BlueControlPhilips Electronics Nederland B.V.20171—
+4K170850Alma QAlma Lasers, Ltd.20172—
+4K163196ACTION II Laser SystemLutronic Corporation20170—
+4K161941Pulsaderm Acne DeviceNutra Luxe MD, LLC20164—
+4K160880Photonica ProfessionalWard Photonics, LLC20166—
+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—
+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—
+4K141975Waterlase Iplus SBiolase, Inc.20150—
+4K142952InMode Diolaze DeviceInmode MD, Ltd.20150—