510(k) Report

Devices descending from K933880

1,212 later devices reach SL Series Surgical Laser Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K060216Energist Ultra VPL Intense Pulse Light SystemEnergist, Ltd.20060—
+4K060234Mccue Energist Ultra VPL Intense Pulse Light SystemMccue Plc20068—
+4K052991Radiancy Facial Skincare DeviceRadiancy (Israel), Ltd.20060—
+4K052688Ellipse Flex PPT, Model 9ESF7255Danish Dermatologic Development A/S200523—
+4K051259Versaclear Skin Therapy System, Model 100Theralight, Inc.200547—
+4K050216Omnilux Revive and Omnilux PlusPhoto Therapeutics Limited2005160—
+4K043032Dealight IplEuropro, Inc.20050—
+4K051359Candela Family of Pulsed Dye Laser Systems: Pigmented Lesion Handpiece AccessoryCandela Corp.200511
+4K050841Fraxel SR Laser SystemReliant Technologies, Inc.2005238—
+4K051255Lumiphase-ROpusmed, Inc.2005143—
+4K042630Revlight Skin Care SystemSkincare Technology, Inc.2005402—
+4K050047Cutera Optional Pulsed Light Hand Piece FamilyCutera, Inc.2005109—
+4K043575Dermillume, Model PRO1000Care Electronics, Inc.20054—
+4K050218Wavelight SinonWavelight Laser Technologie AG20050—
+4K042496Adept Ultralite 532 LaserAdept Medical Concepts200423—
+4K040617Reliant Laser System IIReliant Technologies, Inc.2004316—
+4K033946Lovely SystemMsq (M2), Ltd.2004737—
+4K040156Ifl Professional System, Model C100Cyden Limited20040—
+4K033933Powerlite 600 EX SystemPreswede AB20040—
+4K021650Athoscan for the Athos Laser Constans Cooling Hand Piece for the Athos LaserQuantel Medical20020—
+4K014253Dermachiller 4Paradigm Trex, LLC200250—
+4K013748Candela Sclero Long Pulse Laser (Aka Vbeam)Candela Corp.2002699—
+5K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+5K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+5K252561BTL-754FFBTL Industries, Inc.20260—
+5K250776Lithoblast Single Use Holmium Laser FibersDawell Medical, LLC20250—
+5K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+5K250165PastelleWontech Co., Ltd.20250—
+5K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+5K250189AdvaTxAdvalight Aps20250—
+5K243630Medical Laser System Incanto / Evoline Platinum /EvolineSolar LS Cjsc20250—
+5K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+5K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) Co., Ltd.20250—
+5K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+5K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+5K231948MediyagMedicreations, LLC20240—
+5K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+5K233876Unity VCS (8065000296); Unity CS (8065000297)Alcon Laboratories, Inc.202402
+5K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+5K233473Deka LotusEl.En S.P.A.20241—
+5K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+5K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC20240—
+5K234057NirvanaEl.En S.P.A.20240—
+5K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+5K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+5K231910DermRays ReviveWuhan Lotuxs Technology Co., Ltd.20240—
+5K232106Air Gap FiberWontech Co., Ltd.20240—
+5K221766SolonLmg Lasers Comercio, Importacao E Exportacao Ltda20240—
+5K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+5K232716Q-Switched Nd:Yag laserHebei Zhemai Technology Co., Ltd.20231—
+5K232236EchoQuanta System Spa20230—
+5K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd.20230—
+5K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+5K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+5K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+5K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+5K22079410PLTentech Co., Ltd.20220—
+5K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+5K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+5K212790XLase PlusBiotec Italia, Srl20220—
+5K221571InMode Multi-systemInMode, Ltd.20222—
+5K213261EpilMENeauvia North America20220—
+5K220189LISA Laser Surgical FibersOmni-Guide Holdings, Inc.20225—
+5K210183Waterlase iPLusBiolase, Inc.20220—
+5K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+5K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+5K203728DarwinLuvo Medical Technologies, Inc.20211—
+5K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+5K201171LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe DisposableLeoni Fiber Optics, Inc.20210—
+5K203054FlexSysGme German Medical Engineering GmbH20210—
+5K202361UltraSlim Digital, UltraSmooth DigitalWard Photonics, LLC20200—
+5K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+5K202172StarWalkerFotona D.O.O.20203—
+5K200616E>EyeCE-Swin20200—
+5K200746IPL Treatment SystemsShanghai Apolo Medical Technology Co., Ltd.20205—
+5K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+5K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+5K193367elysion-proHigh Technology Products S.L.U20203—
+5K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+5K200234Surgical laser fibersQuanta System Spa20202—
+5K191693BC-5Reveallux, Corp20190—
+5K183708Poly ClearMedtek Skincare, LLC201922—
+5K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+5K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+5K182930PerioLase Nd:YAG Pulsed Dental Laser SystemMillennium Dental Technologies, Inc.20190—
+5K190938Phototherapy SystemShanghai Apolo Medical Technology Co., Ltd.201916—
+5K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+5K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+5K181510Echolaser X4El.En Electronic Engineering Spa20183—
+5K180900LED Light Therapy DeviceUvbiotek, LLC201829—
+5K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+5K180508Joule SystemSciton, Inc20183—
+5K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+5K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+5K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+5K172819LightWalker Laser System FamilyFotona D.O.O.201720—
+5K172413MT ONEM&T S.R.L.20175—
+5K171227StarWalkerFotona D.O.O.20177—
+5K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+5K171055Philips BlueControlPhilips Electronics Nederland B.V.20171—