510(k) Report

Devices descending from K970934

304 later devices reach CB Erbium/2.94(TM) ER:Yag Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+1K974641Futurelase 3000/3002 Erbium Laser SystemBuckman Co., Inc.1998241—
+1K980361Dermablate ER: Yag Laser SystemAesculap-Meditec North America1998178—
+1K974460Lite Touch Erbium Laser Treatment SystemLorad Corp.19980—
+2K063571Palomar LUX2940 HandpiecePalomar Medical Technologies, Inc.2007160—
+2K021508Opusduo EC Dental Laser SystemOpusdent, Ltd.2002240—
+2K014057Dermastar ER:Yag Laser SystemAsclepion-Meditec AG200218—
+3K101506LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc.2010156—
+3K091320Spectra SP II, Spectra Denta IILutronic Corporation200912—
+3K083253Lotus II Pulsed ER: Yag Laser SystemLaseroptek Co., Ltd.20091—
+3K083900Erbium Fractional HandpiecePalomar Medical Products, Inc.2009158—
+3K071152Palomar Erbium HandpiecePalomar Medical Products, Inc.2007159—
+3K040270Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus SpectrumLumenis, Ltd.2004226—
+3K032599Medical Laser Technologies, LLC MTL Erbium:Yag Laser SystemMedical Laser Technologies, LLC200313—
+3K030181International Biophysics Corporation (Ibc) Laser Peel SystemInternational Biophysics Corp.20030—
+3K021946Cell Robotics Ultra-Light Peel Laser SystemCell Robotics, Inc.20020—
+4K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+4K132661LightscalpelLightscalpel, LLC20143—
+4K123494SOLEAConvergent Dental, Inc.201331
+4K110897Cortex CO2 / ER:Yag Laser SystemSandstone Medical Technologies, LLC20112—
+4K110907Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc.201157—
+4K110502Triplex ER. Yag / ND: Yag SystemSandstone Medical Technologies, LLC20112—
+4K110304Apex ER. Yag / Ipl SystemSandstone Medical Technologies, LLC20112—
+4K101916Joule Multi-Platform SystemSciton, Inc2011111—
+4K103664Primus Aesthetic PlatformPalomar Medical Technologies, Inc.20117—
+4K100610Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser SystemsLutronic Corporation20113—
+4K100270Artisan Aesthetic SystemPalomar Medical Technologies, Inc.2010157—
+4K082028Laserpeel Soft-Met Modified Erbium LaserGlobal USA Distribution, LLC20080—
+4K070138Cutera ER:Yag Laser HandpieceCutera, Inc.20071—
+4K063867Cutera ER:Ysgg Laser HandpieceCutera, Inc.20072—
+4K061966Litetouch Dental Laser SystemLight Instrument, Ltd.20063—
+4K060033Profile Multi-Platform SystemSciton, Inc2006221—
+5K244060eCO2 3DLutronic Corporation20250—
+5K233473Deka LotusEl.En S.P.A.20241—
+5K213761Joule diVa SystemSciton, Inc20220—
+5K192856MT OneM&T S.R.L.20202—
+5K193656SkyPulseFotona D.O.O.202011—
+5K173285Joule SystemSciton, Inc20185—
+5K170073LightMed Dental Laser SystemLightmed Dentaltechnology Corp.20170—
+5K153229SuperbiumBios S.R.L.20162—
+5K151306SoleaConvergent Dental, Inc.20151—
+5K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+5K141975Waterlase Iplus SBiolase, Inc.20150—
+5K141658Light ScalpelLightscalpel, LLC20142—
+5K142376Palomar Icon Aesthetic SystemCynosure, Inc.201413—
+5K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+5K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+5K132976AdvatxAdvalight Aps20141—
+5K130028Resurfx 1565NM Laser ModuleLumenis, Ltd.201341—
+5K130420SOLEAConvergent Dental, Inc.201321
+5K122368Waterlase Iplus All Tissue LaserBiolase Technology, Inc.20130—
+5K123777Multilaser SystemUltralight Laser Technologies, LLC20131—
+5K120622Palomar Vectus LaserPalomar Medical Technologies, Inc.20124—
+5K111831MX-7000 MicroxelBio-Med USA, Inc.20111—
+5K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+5K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+5K080530Modification to Cutera ER:Ysgg Laser HandpieceCutera, Inc.20081—
+5K073411LiteduoLight Instruments20081—
+5K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc.2008202—
+5K070388Profile Multi-Platform SystemSciton, Inc2007129—
+6K252561BTL-754FFBTL Industries, Inc.20260—
+6K250189AdvaTxAdvalight Aps20250—
+6K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+6K250281Deka LotusEl.En S.P.A.20250—
+6K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+6K241270BTL-754BTL Industries, Inc.20251—
+6K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+6K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+6K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+6K233143PiXel8-RevealRohrer Aesthetics20240—
+6K230077LaserMENeauvia North America20232—
+6K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+6K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+6K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+6K213669Lightscalpel LS-4020Lightscalpel, Inc.20230—
+6K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+6K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+6K221761SoleaConvergent Dental, Inc.202201
+6K210183Waterlase iPLusBiolase, Inc.20220—
+6K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+6K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+6K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+6K193367elysion-proHigh Technology Products S.L.U20203—
+6K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+6K193426Elite iQCynosure, LLC20201—
+6K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+6K173827LightScalpelLightscalpel, LLC20180—
+6K173359Fractional CO2 Surgical Laser SystemAmi, Inc.20180—
+6K180508Joule SystemSciton, Inc20183—
+6K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+6K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+6K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+6K163196ACTION II Laser SystemLutronic Corporation20170—
+6K162765Venus Velocity Diode Laser SystemVenus Concept, Ltd.20171—
+6K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+6K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+6K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+6K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+6K141237Harmony LiteAlma, Inc.20154—
+6K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—