510(k) Report

Devices descending from K011382

766 later devices reach Xtrac Excimer Laser System, Model AL 7000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K202988Tixel SystemNovoxel, Ltd.20211—
+6K200971308nm Excimer SystemXuzhou Kernel Medical Equipment Co., Ltd.20201—
+6K193201BTL-785FBtl20208—
+6K201164Venus Viva MD DeviceVenus Concept USA, Inc.20203—
+6K200104OxylightRaja Trading Company, Inc.202024—
+6K200746IPL Treatment SystemsShanghai Apolo Medical Technology Co., Ltd.20205—
+6K191065Venus VivaTMVenus Concept USA, Inc.20200—
+6K193367elysion-proHigh Technology Products S.L.U20203—
+6K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+6K192755Soli-Lite LG4 GalileoSilhouet-Tone Corporation20193—
+6K191942MT One DiamondM&T S.R.L.20191—
+6K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+6K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+6K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+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—
+6K170187Photodynamic Therapy DeviceUvbiotek, LLC20170—
+6K162556Lightfusion Led SystemVitage Led, Ltd.20170—
+6K162098LED Phototherapy DeviceLi-Tek Electronic Technology Corporation201775—
+6K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+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—
+6K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+6K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+6K142093V20 SystemViora, Ltd.201432—
+6K140727Cutera Picosecond Laser SystemCutera, Inc.201447—
+6K142376Palomar Icon Aesthetic SystemCynosure, Inc.201413—
+6K133945Cutera Picosecond Laser SystemCutera, Inc.201414—
+6K133364Picosure WorkstationCynosure, Inc.201451—
+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—
+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—
+6K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+6K073322Fox 1-980, Fox Q-1064, Fox-Q-810A.R.C Laser GmbH200822—
+7K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+7K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+7K261964Echolaser X4Elesta S.P.A20260—
+7K261204Intense Pulsed Light Therapy DeviceSanhe LEFIS Electronics Co., Ltd.20260—
+7K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+7K260688Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+7K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+7K243854Contour Light (CL-100)Contour Research, LLC20261—
+7K252786Led Light Phototherapy Bed (Pro 450/ GY-680A)Shenzhen Suyzeko Limited.20250—
+7K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+7K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+7K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+7K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) Co., Ltd.20250—
+7K250281Deka LotusEl.En S.P.A.20250—
+7K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+7K242977308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D…Xuzhou Kernel Medical Equipment Co., Ltd.20250—
+7K241270BTL-754BTL Industries, Inc.20251—
+7K243139Reverso Pro SystemIndiba S. A. U.20250—
+7K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+7K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+7K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—
+7K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+7K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+7K233344Regenalase Laser SystemIpg Medical20240—
+7K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+7K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+7K232977Biophotas Celluma CONTOURBiophotas, Inc.20235—
+7K230490PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-NA…Dongguan Hunter Electronic Technology Co., Ltd.20230—
+7K232192Venus Versa PRO SystemVenus Concept, Inc.20230—
+7K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd.20230—
+7K231394Intense Pulsed Light SystemSmedtrum Medical Technology Co., Ltd.20232—
+7K230077LaserMENeauvia North America20232—
+7K223033Tixel® 2 SystemNovoxel, Ltd.20230—
+7K223680Eneka ProTermosalud20230—
+7K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+7K222701MANTA LaserSqualus Med, Ltd.20222—
+7K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—