510(k) Report

Devices descending from K040005

572 later devices reach Profile 2000/3000 Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+4K231948MediyagMedicreations, LLC20240—
+4K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+4K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+4K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+4K233473Deka LotusEl.En S.P.A.20241—
+4K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+4K234057NirvanaEl.En S.P.A.20240—
+4K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+4K221766SolonLmg Lasers Comercio, Importacao E Exportacao Ltda20240—
+4K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+4K232716Q-Switched Nd:Yag laserHebei Zhemai Technology Co., Ltd.20231—
+4K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+4K22079410PLTentech Co., Ltd.20220—
+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—
+4K212790XLase PlusBiotec Italia, Srl20220—
+4K221571InMode Multi-systemInMode, Ltd.20222—
+4K210183Waterlase iPLusBiolase, Inc.20220—
+4K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+4K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+4K203728DarwinLuvo Medical Technologies, Inc.20211—
+4K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+4K203299CellFX SystemPulse Biosciences, Inc.20214—
+4K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+4K200616E>EyeCE-Swin20200—
+4K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+4K193367elysion-proHigh Technology Products S.L.U20203—
+4K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+4K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+4K180359BTL-FR2000BTL Industries, Inc.20189—
+4K180508Joule SystemSciton, Inc20183—
+4K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+4K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+4K172413MT ONEM&T S.R.L.20175—
+4K163196ACTION II Laser SystemLutronic Corporation20170—
+4K163551LenSx Laser SystemAlcon Laboratories, Inc.20173—
+4K160075Accent XLAlma Lasers, Inc.20160—
+4K152714Quanta ForteQuanta System Spa201513—
+4K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+4K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+4K151655CO2RE SystemSyneron Medical, Ltd.20151—
+4K151161VICTUS Femtosecond Laser PlatformTechnolas Perfect Vision GmbH20152—
+4K150161Venus Viva SR DeviceVenus Concept, Ltd.20159—
+4K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+4K143010LENSAR Laser System - fs 3DLensar, Inc.20153—
+4K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+4K141852Ifs Advanced Femtosecond Laser SystemAmo Manufacturing USA, LLC20155—
+4K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+4K141476Wavelight FS200 Laser SystemAlcon Research, Ltd. Dba Alcon Laboratories, Inc.20148—
+4K142376Palomar Icon Aesthetic SystemCynosure, Inc.201413—
+4K133774AtovenBio-Med USA, Inc.20146—
+4K133837Viora V-TotalViora, Ltd.201433—
+4K130501IntensifEndymed Medical, Ltd.201457—
+4K132534Victus Femtosecond Laser PlatformTechnolas Perfect Vision GmbH20145—
+4K131758Surgen UPollogen, Ltd.20135—
+4K130028Resurfx 1565NM Laser ModuleLumenis, Ltd.201341—
+4K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+4K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—
+4K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+4K123120Lensx Laser SystemAlcon Lensx, Inc.20125—
+4K121091Catalys Precision Laser SystemOptimedica Corporation2012122
+4K120622Palomar Vectus LaserPalomar Medical Technologies, Inc.20124—
+4K120513Glow by EndymedEndymed Medical, Ltd.20125—
+4K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+4K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+4K110672Etwo Skin Treatment SystemSyneron, Ltd.20112—
+4K102954Cutera Qswitch Laser SystemCutera, Inc.201149—
+4K103288Deka Synchro FTEl.En Electronic Engineering Spa201118—
+4K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc.2010921
+4K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+4K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+4K100558Quanta Diode Laser SystemQuanta System Spa201068—
+4K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+4K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+5K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+5K261964Echolaser X4Elesta S.P.A20260—
+5K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+5K260153Q-Switched Nd: YAG Laser System (Glamor Q)Nanjing Bestview Laser S&T Co., Ltd.20260—
+5K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+5K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+5K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+5K250165PastelleWontech Co., Ltd.20250—
+5K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology 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—
+5K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+5K250281Deka LotusEl.En S.P.A.20250—
+5K241270BTL-754BTL Industries, Inc.20251—
+5K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+5K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—
+5K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+5K233344Regenalase Laser SystemIpg Medical20240—
+5K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+5K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+5K230077LaserMENeauvia North America20232—
+5K223566ELITA™ Femtosecond Laser System, ELITA™ Patient InterfaceJohnson & Johnson Surgical Vision, Inc.20230—
+5K223680Eneka ProTermosalud20230—
+5K222701MANTA LaserSqualus Med, Ltd.20222—