510(k) Report

Devices descending from K971207

781 later devices reach Softlight Q-Switched (ND:Yag) Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K250189AdvaTxAdvalight Aps20250—
+6K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+6K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+6K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+6K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+6K233473Deka LotusEl.En S.P.A.20241—
+6K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+6K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+6K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+6K230373HELIOS 785 PicoLaseroptek Co., Ltd.20232—
+6K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+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—
+6K213267Dynamis Pro FamilyFotona D.O.O.20222—
+6K221427V-LaserWontech Co., Ltd.20222—
+6K210183Waterlase iPLusBiolase, Inc.20220—
+6K213350mJOULE System and AccessoriesSciton, Inc20220—
+6K210847UltraClear Fractional Laser SystemFa International, LP20210—
+6K212607DarwinLuvo Medical Technologies, Inc.20210—
+6K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+6K211444CellFX SystemPulse Biosciences, Inc.20213—
+6K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+6K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+6K202955Contour Light CL-100Contour Research, LLC20218—
+6K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+6K202988Tixel SystemNovoxel, Ltd.20211—
+6K193201BTL-785FBtl20208—
+6K201164Venus Viva MD DeviceVenus Concept USA, Inc.20203—
+6K200104OxylightRaja Trading Company, Inc.202024—
+6K200746IPL Treatment SystemsShanghai Apolo Medical Technology Co., Ltd.20205—
+6K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+6K191065Venus VivaTMVenus Concept USA, Inc.20200—
+6K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+6K193367elysion-proHigh Technology Products S.L.U20203—
+6K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+6K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+6K192755Soli-Lite LG4 GalileoSilhouet-Tone Corporation20193—
+6K191942MT One DiamondM&T S.R.L.20191—
+6K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+6K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+6K190936Q-Switched Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20194—
+6K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+6K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+6K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+6K173692D-Actor 200 Vibration Massage SystemStorz Medical AG20186—
+6K173677InMode VLazeInmode MD, Ltd.20183—
+6K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+6K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+6K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+6K171648BM.IrisBluecore Co., Ltd.20172—
+6K170187Photodynamic Therapy DeviceUvbiotek, LLC20170—
+6K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+6K162556Lightfusion Led SystemVitage Led, Ltd.20170—
+6K162098LED Phototherapy DeviceLi-Tek Electronic Technology Corporation201775—
+6K163222Discovery Pico FamilyQuanta System Spa201630—
+6K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+6K162781Magma SparkFormatk Systems, Ltd.20160—
+6K161670Lucid Q-PTP / HWA 55Bison Medical Co, Ltd.20164—
+6K160312Fraxis DuoIlooda Co,., Ltd.201614—
+6K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+6K153717Venus Versa SystemVenus Concept, Ltd.20161—
+6K152280BioPhotas Celluma3Biophotas, Inc.201649—
+6K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+6K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+6K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+6K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+6K142093V20 SystemViora, Ltd.201432—
+6K140727Cutera Picosecond Laser SystemCutera, Inc.201447—
+6K142376Palomar Icon Aesthetic SystemCynosure, Inc.201413—
+6K140837Lucid LYBio-Med USA, Inc.20140—
+6K133945Cutera Picosecond Laser SystemCutera, Inc.201414—
+6K133364Picosure WorkstationCynosure, Inc.201451—
+6K131757Tattoostar Effect ComboAsclepion Laser Technologies GmbH20140—
+6K133774AtovenBio-Med USA, Inc.20146—
+6K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+6K131113Biophotas CellumaBiophotas, Inc.201455—
+6K131095Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa201317—
+6K131859Multifunctional SeriesBeijing Honkon Technologies Co., Ltd.20133—
+6K130028Resurfx 1565NM Laser ModuleLumenis, Ltd.201341—
+6K123435Ipl Therapy SystemBeijing Sincoheren S&T Development Co, Ltd.20130—
+6K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+6K122995Intense Pulsed Light (Ipl) SystemsBeijing Kes Biology Technology Co., Ltd.201316—
+6K122922E-Beam ND: Yag LaserEclipse Aesthetics, LLC20137—
+6K121346Picosure WorkstationCynosure, Inc.201287—
+6K120622Palomar Vectus LaserPalomar Medical Technologies, Inc.20124—
+6K110375Blueshine's Gold SeriesBlueshine Srl20124—
+6K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+6K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+6K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc.201126—
+6K102857Ahwon's Ipl SystemAhwon Medi Instrument Co., Ltd.20112—
+6K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc.201046—
+6K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+6K100143Pilot Diode Laser, Model 002-00139CAO Group, Inc.201020—
+6K100558Quanta Diode Laser SystemQuanta System Spa201068—
+6K090762LEDAQuantel Derma GmbH200946—
+6K083682180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc.2009121—
+6K082938EzlaseBiolase Technology, Inc.200850—
+6K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+6K082445CURATIVE980 Diode LaserOroscience, Inc.20080—
+6K081015Ceralas D 980NM Diode Laser, Models D15 and D25Biolitec, Inc.200834—