510(k) Report

Devices descending from K980420

1,494 later devices reach Lightsheer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K060033Profile Multi-Platform SystemSciton, Inc2006221—
+5K053324Chromolite SystemChromogenex Plc200631—
+5K051214Aluma Skin Renewal SystemLumenis, Inc.2005476—
+5K051259Versaclear Skin Therapy System, Model 100Theralight, Inc.200547—
+5K051876Multiwave XRPacific Quantum Instruments, Inc.20050—
+5K050216Omnilux Revive and Omnilux PlusPhoto Therapeutics Limited2005160—
+5K043032Dealight IplEuropro, Inc.20050—
+5K051359Candela Family of Pulsed Dye Laser Systems: Pigmented Lesion Handpiece AccessoryCandela Corp.200511
+5K050841Fraxel SR Laser SystemReliant Technologies, Inc.2005238—
+5K051255Lumiphase-ROpusmed, Inc.2005143—
+5K042630Revlight Skin Care SystemSkincare Technology, Inc.2005402—
+5K050397Velasmooth, ShaperSyneron Medical, Ltd.2005150—
+5K050047Cutera Optional Pulsed Light Hand Piece FamilyCutera, Inc.2005109—
+5K042319Reliant Laser II System and AccessoriesReliant Technologies, Inc.2005284—
+5K043575Dermillume, Model PRO1000Care Electronics, Inc.20054—
+5K050218Wavelight SinonWavelight Laser Technologie AG20050—
+5K041959Polaris DS/CometSyneron Medical, Ltd.2004301—
+5K041969Aurora DSSyneron Medical, Ltd.2004302—
+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—
+6K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+6K252561BTL-754FFBTL Industries, Inc.20260—
+6K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+6K251094Alma VeilWontech Co., Ltd.20250—
+6K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) Co., Ltd.20250—
+6K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+6K243362SmoothSkin Pure Switch (SSC1)Cyden Limited20241—
+6K231948MediyagMedicreations, LLC20240—
+6K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+6K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+6K233473Deka LotusEl.En S.P.A.20241—
+6K234057NirvanaEl.En S.P.A.20240—
+6K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+6K240587SmoothSkin Pure Unplugged (SSB3)Cyden Limited20240—
+6K221766SolonLmg Lasers Comercio, Importacao E Exportacao Ltda20240—
+6K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+6K233782SmoothSkin Pure Adapt (SSG3)Cyden Limited20232—
+6K232716Q-Switched Nd:Yag laserHebei Zhemai Technology Co., Ltd.20231—
+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—
+6K230107Aimanfun Lumea Comfort, Model: A-2788, A-2789 and A-3588Kam Yuen Plastic Products, Ltd.20230—
+6K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+6K22079410PLTentech Co., Ltd.20220—
+6K221214Hand-held IPL device (IPL Home Use Hair Removal Device) Model:FZ-608, FZ-608G, FZ-100…Shenzhen Ionka Medical Technology Co., Ltd.202212—
+6K221635IPL sapphire ice cooling hair remove deviceShenzhen Desida Technology Co., Ltd.20220—
+6K221427V-LaserWontech Co., Ltd.20222—
+6K212790XLase PlusBiotec Italia, Srl20220—
+6K213761Joule diVa SystemSciton, Inc20220—
+6K221679IPL Hair Remover, Model: G993, G996, G998 and G885Shenzhen Mywin Technology Co., Ltd.20220—
+6K221571InMode Multi-systemInMode, Ltd.20222—
+6K213558IPL Hair Removal DeviceUlike Co., Ltd.202215—
+6K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+6K212907Aimanfun Lumea Comfort, A-2789/A-3588Kam Yuen Plastic Products, Ltd.202114—
+6K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+6K213041IPL Hair Removal, Model: OBT-02Glan Electronics Co., Ltd.202115—
+6K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+6K211174IPL Hair RemovalShenzhen Qiaochengli Technology Co., Ltd.20210—
+6K203728DarwinLuvo Medical Technologies, Inc.20211—
+6K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+6K203054FlexSysGme German Medical Engineering GmbH20210—
+6K202361UltraSlim Digital, UltraSmooth DigitalWard Photonics, LLC20200—
+6K202172StarWalkerFotona D.O.O.20203—
+6K192621Medical RFTriworks Group Srl20200—
+6K200616E>EyeCE-Swin20200—
+6K200746IPL Treatment SystemsShanghai Apolo Medical Technology Co., Ltd.20205—
+6K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+6K193656SkyPulseFotona D.O.O.202011—
+6K191693BC-5Reveallux, Corp20190—
+6K183708Poly ClearMedtek Skincare, LLC201922—
+6K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+6K190938Phototherapy SystemShanghai Apolo Medical Technology Co., Ltd.201916—
+6K183260Sensilight Pro / Pistol IPLEl Global Trade, Ltd.20190—
+6K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+6K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+6K180900LED Light Therapy DeviceUvbiotek, LLC201829—
+6K180508Joule SystemSciton, Inc20183—
+6K173692D-Actor 200 Vibration Massage SystemStorz Medical AG20186—
+6K173677InMode VLazeInmode MD, Ltd.20183—
+6K173285Joule SystemSciton, Inc20185—
+6K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+6K172819LightWalker Laser System FamilyFotona D.O.O.201720—
+6K172413MT ONEM&T S.R.L.20175—
+6K170179LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer InfinityLumenis, Ltd.201714—
+6K171227StarWalkerFotona D.O.O.20177—
+6K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+6K171055Philips BlueControlPhilips Electronics Nederland B.V.20171—
+6K163196ACTION II Laser SystemLutronic Corporation20170—
+6K161941Pulsaderm Acne DeviceNutra Luxe MD, LLC20164—
+6K160880Photonica ProfessionalWard Photonics, LLC20166—
+6K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+6K160968iPulse SmoothSkin Gold Hair Removal DeviceCyden Limited2016117—
+6K153566Magma SystemFormatk Systems, Ltd.20162—
+6K153081Clear Bi-LightMichael Todd, LP201646—
+6K152714Quanta ForteQuanta System Spa201513—