510(k) Report

Devices descending from K024093

756 later devices reach Modified Lumenis Family of Intense Pulsed-Light (Ipl) and Combination Ipl… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K221571InMode Multi-systemInMode, Ltd.20222—
+5K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+5K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+5K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+5K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+5K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+5K202955Contour Light CL-100Contour Research, LLC20218—
+5K210451OrthoGold 100Tissue Regeneration Technologies, LLC20212—
+5K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+5K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+5K203299CellFX SystemPulse Biosciences, Inc.20214—
+5K193266MIINMedico USA, Inc.20210—
+5K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+5K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+5K201406PicowonWontech Co., Ltd.20200—
+5K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+5K200736Stardust MedI.T.S. Group S.R.L.20200—
+5K200104OxylightRaja Trading Company, Inc.202024—
+5K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+5K200746IPL Treatment SystemsShanghai Apolo Medical Technology Co., Ltd.20205—
+5K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+5K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+5K192755Soli-Lite LG4 GalileoSilhouet-Tone Corporation20193—
+5K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+5K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+5K180359BTL-FR2000BTL Industries, Inc.20189—
+5K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+5K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+5K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+5K173199PicoSure WorkstationCynosure, Inc.20189—
+5K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+5K171227StarWalkerFotona D.O.O.20177—
+5K170187Photodynamic Therapy DeviceUvbiotek, LLC20170—
+5K162755PicocareWontech Co., Ltd.20179—
+5K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+5K162556Lightfusion Led SystemVitage Led, Ltd.20170—
+5K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+5K162098LED Phototherapy DeviceLi-Tek Electronic Technology Corporation201775—
+5K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+5K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+5K160075Accent XLAlma Lasers, Inc.20160—
+5K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+5K152856Helios IIILaseroptek Co., Ltd.20165—
+5K160480PicoSure WorkstationCynosure, Inc.201620—
+5K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+5K152280BioPhotas Celluma3Biophotas, Inc.201649—
+5K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+5K152611V20 systemViora, Ltd.20164—
+5K150161Venus Viva SR DeviceVenus Concept, Ltd.20159—
+5K150035V10 systemViora, Ltd.201531—
+5K150326PicoWay Laser SystemCandela Corporation201568—
+5K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa201516—
+5K143105Picosure WorkstationCynosure, Inc.201549—
+5K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+5K142372Pico Way Laser SystemCandela Corpation201470—
+5K140719Picosure WorkstationCynosure, Inc.201450—
+5K130501IntensifEndymed Medical, Ltd.201457—
+5K131113Biophotas CellumaBiophotas, Inc.201455—
+5K131758Surgen UPollogen, Ltd.20135—
+5K131859Multifunctional SeriesBeijing Honkon Technologies Co., Ltd.20133—
+5K123435Ipl Therapy SystemBeijing Sincoheren S&T Development Co, Ltd.20130—
+5K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+5K122995Intense Pulsed Light (Ipl) SystemsBeijing Kes Biology Technology Co., Ltd.201316—
+5K120513Glow by EndymedEndymed Medical, Ltd.20125—
+5K110375Blueshine's Gold SeriesBlueshine Srl20124—
+5K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+5K110364Dornier Medilas D Litebeam+ 1470Dornier Medtech America, Inc.20117—
+5K110672Etwo Skin Treatment SystemSyneron, Ltd.20112—
+5K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+5K110907Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc.201157—
+5K103664Primus Aesthetic PlatformPalomar Medical Technologies, Inc.20117—
+5K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc.201126—
+5K102857Ahwon's Ipl SystemAhwon Medi Instrument Co., Ltd.20112—
+5K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc.201046—
+5K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+5K100143Pilot Diode Laser, Model 002-00139CAO Group, Inc.201020—
+5K100558Quanta Diode Laser SystemQuanta System Spa201068—
+5K100270Artisan Aesthetic SystemPalomar Medical Technologies, Inc.2010157—
+5K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+5K090762LEDAQuantel Derma GmbH200946—
+5K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+5K083682180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc.2009121—
+5K082938EzlaseBiolase Technology, Inc.200850—
+5K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+5K082445CURATIVE980 Diode LaserOroscience, Inc.20080—
+5K080530Modification to Cutera ER:Ysgg Laser HandpieceCutera, Inc.20081—
+5K081015Ceralas D 980NM Diode Laser, Models D15 and D25Biolitec, Inc.200834—
+5K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+5K073322Fox 1-980, Fox Q-1064, Fox-Q-810A.R.C Laser GmbH200822—
+6K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+6K252723Dynamis Pro FamilyFotona D.O.O.20260—
+6K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+6K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+6K261964Echolaser X4Elesta S.P.A20260—
+6K261204Intense Pulsed Light Therapy DeviceSanhe LEFIS Electronics Co., Ltd.20260—
+6K260688Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+6K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+6K243854Contour Light (CL-100)Contour Research, LLC20261—
+6K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+6K252786Led Light Phototherapy Bed (Pro 450/ GY-680A)Shenzhen Suyzeko Limited.20250—