510(k) Report

Devices descending from K014234

784 later devices reach Medlite IV Q-Switchednd: Yaglaser Replaced by the Medlite C6 Q-Swicthed ND… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+1K142372Pico Way Laser SystemCandela Corpation201470—
+1K133158ND: Yag Laser SystemBeijing Toplaser Technology Co., Ltd.20145—
+1K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—
+1K083203Helios II Q-Switched ND:Yag Laser SystemLaseroptek Co., Ltd.20096—
+1K063112Revlite Q-Switched ND:Yag LaserHoya Conbio, Inc.2006169—
+1K061850Mini-Yag LaserAmerican Lasers, Inc.20060—
+1K060977Medlite C Series Compression Tool and Handpiece Attachment Accessory, Model 659-0523Hoya Conbio, Inc.20060—
+1K053139Fotona QX ND:Yag/KTP Laser SystemFotona D.D.2006168—
+1K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd.2004517—
+1K033946Lovely SystemMsq (M2), Ltd.2004737—
+1K033251The Friendlylight ND: Yag LasersInnotech USA, Inc.2004519—
+1K033259Light Age Q-Clear Laser, Model 701-1101Light Age, Inc.200476—
+1K032667Focus Medical 532 Hand Piece Adapter and Dye Pack Accessories (Red or Yellow)Focus Medical, LLC20043—
+2K250165PastelleWontech Co., Ltd.20250—
+2K202288FinebeamSNJ Co., Ltd.20212—
+2K170850Alma QAlma Lasers, Ltd.20172—
+2K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+2K163123Q-Switched Nd:YAG Laser Therapy SystemsBeijing Sincoheren Science and Technology Development Co.20174—
+2K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+2K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+2K152856Helios IIILaseroptek Co., Ltd.20165—
+2K160368EVO platformQuanta System Spa201636—
+2K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+2K151473NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and…Focus Medical, LLC201537—
+2K150326PicoWay Laser SystemCandela Corporation201568—
+2K120235Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag Lasers, Friendlylight Neo…Aerolase Medical Lasers, LLC201233—
+2K110370Q-ClearLight Age, Inc.201135—
+2K083889Fotona QX ND:Yag/KTP Laser System FamilyFotona D.D.2009166—
+2K081408Ellipse MultiflexEllipse A/S20087—
+2K073572Matrix RF ApplicatorSyneron Medical, Ltd.2008102—
+2K082028Laserpeel Soft-Met Modified Erbium LaserGlobal USA Distribution, LLC20080—
+2K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+2K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008266—
+2K072344Apl Medical SystemBios S.R.L.20076—
+2K063427Lumina Intense Pulsed Light (& Laser) SystemLynton Lasers Limited20070—
+2K063571Palomar LUX2940 HandpiecePalomar Medical Technologies, Inc.2007160—
+2K063834Revlite C6 Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2007168—
+2K063249BeamaxMedic Sharplight, Ltd.200758—
+2K052354Oculase MDBiolase Technology, Inc.20065—
+2K060033Profile Multi-Platform SystemSciton, Inc2006221—
+2K053324Chromolite SystemChromogenex Plc200631—
+2K051359Candela Family of Pulsed Dye Laser Systems: Pigmented Lesion Handpiece AccessoryCandela Corp.200511
+2K042630Revlight Skin Care SystemSkincare Technology, Inc.2005402—
+2K043173Q-Switched ND:Yag Laser Treatment Head for the Lumenis Quantum SeriesLumenis, Ltd.200539—
+2K041969Aurora DSSyneron Medical, Ltd.2004302—
+3K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+3K242943Q Switched Nd:YAG Laser machine (QNHF-01)Beijing Nubway S&T Co., Ltd.20250—
+3K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+3K242206ActivoDaeju Meditech Engineering Co., Ltd.20240—
+3K233757TitanPico Laser Workstation (PICO-450)Rhein Laser Technologies Co., Ltd.20240—
+3K233024Alma HarmonyAlma Lasers, Inc.20241—
+3K230308Alma HarmonyAlma Lasers, Inc.20232—
+3K220214Painless IPL System - KDT750Shanghai Omni Laser Skinology Co., Ltd.20230—
+3K213761Joule diVa SystemSciton, Inc20220—
+3K212663Helios IV 785Laseroptek Co., Ltd.20223—
+3K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+3K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+3K202172StarWalkerFotona D.O.O.20203—
+3K192856MT OneM&T S.R.L.20202—
+3K193609Q Switched Nd: YAG Laser machineBeijing Lead Beauty S & T Co., Ltd.20202—
+3K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+3K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—
+3K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+3K191685PicoWay Laser SystemCandela Corporation201920—
+3K183392PicoLO Nd:YAG Picosecond Laser SystemLaseroptek Co., Ltd.20192—
+3K182997enlighten III Laser SystemCutera, Inc.20180—
+3K181272Picocare FamilyWontech Co., Ltd.20188—
+3K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+3K173677InMode VLazeInmode MD, Ltd.20183—
+3K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+3K171227StarWalkerFotona D.O.O.20177—
+3K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+3K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+3K163222Discovery Pico FamilyQuanta System Spa201630—
+3K153229SuperbiumBios S.R.L.20162—
+3K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+3K152012EVO platformQuanta System Spa201537—
+3K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+3K141237Harmony LiteAlma, Inc.20154—
+3K141975Waterlase Iplus SBiolase, Inc.20150—
+3K142860Lumenis M22 SystemLumenis, Ltd.2015381
+3K140670Ellipse I2PL+/Ellipse Multiflex+Ellipse A/S201461
+3K131857Q-Switched ND:Yag LaserBeijing Honkon Technologies Co., Ltd.20140—
+3K131142Genesis Led WandsGenesis Biosystems, Inc.20130—
+3K122368Waterlase Iplus All Tissue LaserBiolase Technology, Inc.20130—
+3K122200A3F FrationalPollogen, Ltd.20130—
+3K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD.20121—
+3K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc.20123—
+3K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+3K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+3K102461FractoraInvasix, Ltd.201124—
+3K103455Spectra Laser SystemLutronic Corporation201192—
+3K101916Joule Multi-Platform SystemSciton, Inc2011111—
+3K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd.201164—
+3K101321Ematrix CO2Syneron Medical, Ltd.20102—
+3K092734E-Light LineEspansione Marketing S.P.A20102—
+3K101506LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc.2010156—
+3K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+3K090025Matrix RF ApplicatorSyneron Medical, Ltd.201018—