510(k) Report

Devices descending from K972347

1,142 later devices reach Modified Coherent Versapulse Aesthetic Surgical Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K043575Dermillume, Model PRO1000Care Electronics, Inc.20054—
+4K043251Candela Family of Pulsed Dye Laser Systems, Models Vbeam, Cbeam, SPTL-1BCandela Corp.2005136—
+4K032397Dual Yellow Laser, Model Dual Yellow D10BNorseld Pty., Ltd.20042—
+4K033946Lovely SystemMsq (M2), Ltd.2004737—
+4K033072Lucentlite, Model Imd 010Industrial & Medical Design, Inc.20040—
+4K040156Ifl Professional System, Model C100Cyden Limited20040—
+4K033933Powerlite 600 EX SystemPreswede AB20040—
+4K033251The Friendlylight ND: Yag LasersInnotech USA, Inc.2004519—
+4K033461Candela Vbeam Pulse Dye Laser SystemCandela Corp.2004316—
+4K032218Adept 1064/532/755 LaserAdept Medical Concepts2003104—
+4K032221Adept 1064/755 LaserAdept Medical Concepts20030—
+4K032220Adept 1064/532 LaserAdept Medical Concepts2003126—
+4K031828Naturalase LP ND:Yag LaserFocus Medical, LLC20035—
+4K023881Profile 1064 Laser SystemSciton, Inc2003227—
+5K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+5K260153Q-Switched Nd: YAG Laser System (Glamor Q)Nanjing Bestview Laser S&T Co., Ltd.20260—
+5K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+5K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+5K252658Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd.20251—
+5K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+5K250261Heager Medical Laser Family (Sabrina/Adolf)Heager GmbH20250—
+5K250165PastelleWontech Co., Ltd.20250—
+5K251632Optimas MAX SystemInMode, Ltd.20251—
+5K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+5K250722Nd: YAG Laser Therapy System (QN-1)Hebei JT Medical Co., Ltd.20250—
+5K250189AdvaTxAdvalight Aps20250—
+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—
+5K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+5K242132FreddoFabinject Lndustria E Comercio Lmportacao E Exportacao Ltda20240—
+5K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+5K233473Deka LotusEl.En S.P.A.20241—
+5K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+5K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+5K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+5K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+5K232117Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)Wuhan Lotuxs Technology Co., Ltd.20231—
+5K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd.20230—
+5K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+5K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+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—
+5K210183Waterlase iPLusBiolase, Inc.20220—
+5K213350mJOULE System and AccessoriesSciton, Inc20220—
+5K220020Cryo 7Zimmer Medizinsysteme GmbH20222—
+5K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+5K210847UltraClear Fractional Laser SystemFa International, LP20210—
+5K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+5K202288FinebeamSNJ Co., Ltd.20212—
+5K212607DarwinLuvo Medical Technologies, Inc.20210—
+5K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+5K211444CellFX SystemPulse Biosciences, Inc.20213—
+5K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+5K203054FlexSysGme German Medical Engineering GmbH20210—
+5K202988Tixel SystemNovoxel, Ltd.20211—
+5K202361UltraSlim Digital, UltraSmooth DigitalWard Photonics, LLC20200—
+5K202172StarWalkerFotona D.O.O.20203—
+5K193201BTL-785FBtl20208—
+5K201164Venus Viva MD DeviceVenus Concept USA, Inc.20203—
+5K200746IPL Treatment SystemsShanghai Apolo Medical Technology Co., Ltd.20205—
+5K191065Venus VivaTMVenus Concept USA, Inc.20200—
+5K193367elysion-proHigh Technology Products S.L.U20203—
+5K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+5K191693BC-5Reveallux, Corp20190—
+5K191942MT One DiamondM&T S.R.L.20191—
+5K183708Poly ClearMedtek Skincare, LLC201922—
+5K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+5K190938Phototherapy SystemShanghai Apolo Medical Technology Co., Ltd.201916—
+5K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+5K180900LED Light Therapy DeviceUvbiotek, LLC201829—
+5K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+5K173677InMode VLazeInmode MD, Ltd.20183—
+5K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+5K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+5K170179LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer InfinityLumenis, Ltd.201714—
+5K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+5K171227StarWalkerFotona D.O.O.20177—
+5K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+5K171055Philips BlueControlPhilips Electronics Nederland B.V.20171—
+5K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+5K160312Fraxis DuoIlooda Co,., Ltd.201614—
+5K161941Pulsaderm Acne DeviceNutra Luxe MD, LLC20164—
+5K160880Photonica ProfessionalWard Photonics, LLC20166—
+5K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+5K153566Magma SystemFormatk Systems, Ltd.20162—
+5K153717Venus Versa SystemVenus Concept, Ltd.20161—
+5K153081Clear Bi-LightMichael Todd, LP201646—
+5K152790Venus Versa SystemVenus Concept, Ltd.20160—
+5K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+5K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+5K152012EVO platformQuanta System Spa201537—
+5K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+5K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+5K150907Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner…Ellipse A/S20155—
+5K140386Lumina 24Rogers Sciences, Inc.20150—
+5K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+5K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+5K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+5K142256Applied BioPhotonics Phototherapy System ABPT1003Applied Biophotonics, Ltd.20150—