510(k) Report

Devices descending from K000317

240 later devices reach Spectra-VRM Q-Switched ND:Yag Laser System, Spectra-VRM through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K061850Mini-Yag LaserAmerican Lasers, Inc.20060—
+1K053139Fotona QX ND:Yag/KTP Laser SystemFotona D.D.2006168—
+1K033259Light Age Q-Clear Laser, Model 701-1101Light Age, Inc.200476—
+2K110370Q-ClearLight Age, Inc.201135—
+2K083203Helios II Q-Switched ND:Yag Laser SystemLaseroptek Co., Ltd.20096—
+2K083889Fotona QX ND:Yag/KTP Laser System FamilyFotona D.D.2009166—
+2K043173Q-Switched ND:Yag Laser Treatment Head for the Lumenis Quantum SeriesLumenis, Ltd.200539—
+3K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+3K202288FinebeamSNJ Co., Ltd.20212—
+3K202172StarWalkerFotona D.O.O.20203—
+3K171227StarWalkerFotona D.O.O.20177—
+3K152856Helios IIILaseroptek Co., Ltd.20165—
+3K152012EVO platformQuanta System Spa201537—
+3K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+3K142860Lumenis M22 SystemLumenis, Ltd.2015381
+3K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+3K103455Spectra Laser SystemLutronic Corporation201192—
+4K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+4K253765Vanish ProDdc Technologies, Inc.20260—
+4K253342PICO-KSpeclipse, Inc.20251—
+4K253344Bellus-QSpeclipse, Inc.20250—
+4K250165PastelleWontech Co., Ltd.20250—
+4K241527Pastelle ProWontech Co., Ltd.20253—
+4K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+4K242206ActivoDaeju Meditech Engineering Co., Ltd.20240—
+4K240752Deka ToroEl.En S.P.A.20240—
+4K212663Helios IV 785Laseroptek Co., Ltd.20223—
+4K192856MT OneM&T S.R.L.20202—
+4K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+4K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+4K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+4K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+4K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+4K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+4K153566Magma SystemFormatk Systems, Ltd.20162—
+4K160368EVO platformQuanta System Spa201636—
+4K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+4K133837Viora V-TotalViora, Ltd.201433—
+4K112669Tattoostar Effect YAsclepion Laser Technologies GmbH20128—
+4K113588Spectra Laser SystemLutronic Corporation201282—
+5K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+5K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical Incorporated20250—
+5K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+5K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+5K234057NirvanaEl.En S.P.A.20240—
+5K231054V-LaserWontech Co., Ltd.20231—
+5K230373HELIOS 785 PicoLaseroptek Co., Ltd.20232—
+5K223540AvalancheLase FamilyFotona D.O.O.20230—
+5K22079410PLTentech Co., Ltd.20220—
+5K213267Dynamis Pro FamilyFotona D.O.O.20222—
+5K212790XLase PlusBiotec Italia, Srl20220—
+5K213350mJOULE System and AccessoriesSciton, Inc20220—
+5K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+5K203728DarwinLuvo Medical Technologies, Inc.20211—
+5K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+5K203788DermaV Laser SystemLutronic Corporation202101
+5K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+5K200616E>EyeCE-Swin20200—
+5K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+5K193656SkyPulseFotona D.O.O.202011—
+5K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+5K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+5K190936Q-Switched Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20194—
+5K183156V-LaserWontech Co., Ltd.20193—
+5K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+5K181518Sebacia MicroparticlesSebacia, Inc.20180—
+5K173692D-Actor 200 Vibration Massage SystemStorz Medical AG20186—
+5K173677InMode VLazeInmode MD, Ltd.20183—
+5K171648BM.IrisBluecore Co., Ltd.20172—
+5K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+5K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+5K163222Discovery Pico FamilyQuanta System Spa201630—
+5K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+5K162781Magma SparkFormatk Systems, Ltd.20160—
+5K161670Lucid Q-PTP / HWA 55Bison Medical Co, Ltd.20164—
+5K142093V20 SystemViora, Ltd.201432—
+5K140837Lucid LYBio-Med USA, Inc.20140—
+5K131757Tattoostar Effect ComboAsclepion Laser Technologies GmbH20140—
+5K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+5K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+5K122922E-Beam ND: Yag LaserEclipse Aesthetics, LLC20137—
+6K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+6K252723Dynamis Pro FamilyFotona D.O.O.20260—
+6K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—
+6K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+6K251094Alma VeilWontech Co., Ltd.20250—
+6K250809Stellar M22Lumenis Be, Ltd.20250—
+6K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+6K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+6K243488Vmat ProTermosalud20250—
+6K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+6K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+6K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+6K233024Alma HarmonyAlma Lasers, Inc.20241—
+6K222790F65 Laser SystemLumenis Be, Ltd.20233—
+6K221865BTL-094BTL Industries, Inc.20230—
+6K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+6K210166Omnispec ED1000Medispec, Ltd.20230—
+6K222221Deka HelixEl.En Electronic Engineering Spa20231—
+6K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—