510(k) Report

Devices descending from K982546

480 later devices reach Phaser-2000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K110301Silk'n FXHome Skinovations, Ltd.201166—
+3K102954Cutera Qswitch Laser SystemCutera, Inc.201149—
+3K103288Deka Synchro FTEl.En Electronic Engineering Spa201118—
+3K100628PlasmaluxlsDaavlin Distributing Co.20100—
+3K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc.2010921
+3K101321Ematrix CO2Syneron Medical, Ltd.20102—
+3K092734E-Light LineEspansione Marketing S.P.A20102—
+3K091467Baby QuasarSilver Bay, LLC20100—
+3K092460Star-Lite -LM, Model SL8809Ps Advanced Engineering20101—
+3K092800Anti-Wrinkle (Aging) Light, Model AalLed Intellectual Properties, LLC201011—
+3K090525Loi SystemPalomar Medical Products, Inc.20099—
+3K081570DPL Therapy SystemLed Technologies, LLC200811
+3K080689Spectra Therapy System A1000 Laser DevicePremier Dynamics, Inc.20080—
+3K061614Terraquant MQ2000 V. 5 and Handyrx MQ2007 LasersEscada International, Inc.200617—
+3K053473Maestro MDTL Laser SystemAdvanced Medical Technologies, Inc.20068—
+3K051816Lumiwave 1X4 Infrared Therapy DeviceBiocare Systems, Inc.200531
+4K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+4K260153Q-Switched Nd: YAG Laser System (Glamor Q)Nanjing Bestview Laser S&T Co., Ltd.20260—
+4K260129Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )Shenzhen Kaiyan Medical Equipment Co., Ltd.20261—
+4K252786Led Light Phototherapy Bed (Pro 450/ GY-680A)Shenzhen Suyzeko Limited.20250—
+4K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+4K250165PastelleWontech Co., Ltd.20250—
+4K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+4K250722Nd: YAG Laser Therapy System (QN-1)Hebei JT Medical Co., Ltd.20250—
+4K250189AdvaTxAdvalight Aps20250—
+4K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+4K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) Co., Ltd.20250—
+4K241947EnergyLounger (TY-01)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+4K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+4K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+4K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+4K233077FlashHeal 2 (FlashHeal 2.0)Inwound Aps20240—
+4K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+4K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+4K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+4K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+4K221189Oliz LTB-1000ALtbio Co., Ltd.20220—
+4K221083Smartlux MiniMedmix Co., Ltd.20222—
+4K210183Waterlase iPLusBiolase, Inc.20220—
+4K212771LightStim ElipsaLed Intellectual Properties, LLC20221—
+4K210847UltraClear Fractional Laser SystemFa International, LP20210—
+4K202288FinebeamSNJ Co., Ltd.20212—
+4K212607DarwinLuvo Medical Technologies, Inc.20210—
+4K200983Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin…Ningbo Hesi Electric Co., Ltd.202146—
+4K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+4K202955Contour Light CL-100Contour Research, LLC20218—
+4K202028dermalux Flex MDAesthetic Technology, Ltd.20205—
+4K200104OxylightRaja Trading Company, Inc.202024—
+4K200751Photodynamic Therapy (PDT) EquipmentShangdong Huamei Technology Co., Ltd.20201—
+4K200659Dermalux Tri-Wave MDAesthetic Technology, Ltd.20203—
+4K193367elysion-proHigh Technology Products S.L.U20203—
+4K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+4K191942MT One DiamondM&T S.R.L.20191—
+4K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+4K181659Avologi ENEOPremier North America, Inc.20184—
+4K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+4K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+4K163137NIRA Beauty Skin LaserDermal Photonics Corporation20171—
+4K170068Softcure 96Wellray Medical Laser, Inc.20170—
+4K162784Silk'n HSTHome Skinovations, Ltd.20171—
+4K162556Lightfusion Led SystemVitage Led, Ltd.20170—
+4K162098LED Phototherapy DeviceLi-Tek Electronic Technology Corporation201775—
+4K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+4K152087HeatLux Pro IIHome Skinovations, Ltd.20160—
+4K152332Perfectio LED infrared deviceOmm Imports Inc Dba Zero Gravity201661—
+4K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+4K151336LightStim Professional 2-Panel LightLed Intellectual Properties, LLC20150—
+4K150554NuBrilliance Light Pain TherapyWellquest International, Inc.20150—
+4K151655CO2RE SystemSyneron Medical, Ltd.20151—
+4K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+4K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+4K142025Neurolumen PN-1000Neurolumen, LLC20150—
+4K142093V20 SystemViora, Ltd.201432—
+4K140727Cutera Picosecond Laser SystemCutera, Inc.201447—
+4K133945Cutera Picosecond Laser SystemCutera, Inc.201414—
+4K133546Starlite-OM, Light Effects, ThibiantPs Advanced Engineering20140—
+4K133364Picosure WorkstationCynosure, Inc.201451—
+4K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+4K131113Biophotas CellumaBiophotas, Inc.201455—
+4K131095Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa201317—
+4K130459Tria Fan SystemTria Beauty, Inc.20131—
+4K130793Newa Skin Therapy SystemEndymion Medical, Ltd.20130—
+4K121346Picosure WorkstationCynosure, Inc.201287—
+4K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+4K082969Luminex Infrared Lamp SystemMedical Laser Systems, Inc.20081—
+4K061656Laser-D68Laser Pain Clinics LP20065—
+5K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+5K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+5K261473ChromixTermosalud S.L.20260—
+5K260715CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd.20260—
+5K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+5K260688Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+5K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+5K243854Contour Light (CL-100)Contour Research, LLC20261—
+5K251042Light Therapy System (M500, L6)Guangzhou Ahead Intelligent Technology Co., Ltd.20251—
+5K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+5K250125LMNT O2Xplr, Ltd.20250—
+5K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+5K242789Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006)Dongguan Laiguang Electronic Technology Co., Ltd.20253—
+5K241293LED Light Therapy Device, ELIXIR MD™Yassen Wellness, LLC20247—