510(k) Report

Devices descending from K981952

763 later devices reach Combination ND:Yag and Frequency Doubled Solid State Green Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063828Diomed Delta 25Diomed, Ltd.20075—
+1K052129Lumenis 1000 Integrated Slit LampLumenis, Inc.20055—
+1K023881Profile 1064 Laser SystemSciton, Inc2003227—
+1K021650Athoscan for the Athos Laser Constans Cooling Hand Piece for the Athos LaserQuantel Medical20020—
+1K014040Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide I, II and…Altus Medical, Inc.2002739—
+1K993671Candela Sclero Long Pulse Dye LaserCandela Corp.2000700—
+1K991234The Acme Medical Aesthetic ND:Yag LaserAcme Medical, Inc.1999755—
+2K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+2K213350mJOULE System and AccessoriesSciton, Inc20220—
+2K161503ORIONYerim Engineering Co., Ltd.20161—
+2K101916Joule Multi-Platform SystemSciton, Inc2011111—
+2K080959Dornier Medilas D 30 Laser, Medilas D 1064Dornier Medtech America, Inc.20084—
+2K060033Profile Multi-Platform SystemSciton, Inc2006221—
+2K052526Novus 3000 Laser System and Delivery DevicesLumenis, Inc.20054—
+2K032218Adept 1064/532/755 LaserAdept Medical Concepts2003104—
+2K032221Adept 1064/755 LaserAdept Medical Concepts20030—
+2K032220Adept 1064/532 LaserAdept Medical Concepts2003126—
+2K031828Naturalase LP ND:Yag LaserFocus Medical, LLC20035—
+2K022923Candela Gentle Yag Laser SystemCandela Corp.2003656—
+2K023193Candela Gentle Yag Laser SystemCandela Corp.2002656—
+2K022226Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future…Altus Medical, Inc.2002665—
+2K013748Candela Sclero Long Pulse Laser (Aka Vbeam)Candela Corp.2002699—
+3K213761Joule diVa SystemSciton, Inc20220—
+3K193656SkyPulseFotona D.O.O.202011—
+3K181510Echolaser X4El.En Electronic Engineering Spa20183—
+3K180224Element-TLElemenic Co., Ltd.20180—
+3K173285Joule SystemSciton, Inc20185—
+3K151337StrialiteCentre Light Solutions, LLC20160—
+3K141975Waterlase Iplus SBiolase, Inc.20150—
+3K140249Long Pulse ND: Yag Laser SystemAdvanced Technology Laser Co., Ltd.20143—
+3K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+3K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+3K132976AdvatxAdvalight Aps20141—
+3K133319ET Lightsheer 1060, High Speed Lightsheer 1060Lumenis, Ltd.201424—
+3K122368Waterlase Iplus All Tissue LaserBiolase Technology, Inc.20130—
+3K110370Q-ClearLight Age, Inc.201135—
+3K103626Cutera Genesisplus Laser SystemCutera, Inc.2011121—
+3K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+3K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198—
+3K083207Ultrawave Iii EX 1320Quanta System Spa2008961
+3K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc.2008202—
+3K070388Profile Multi-Platform SystemSciton, Inc2007129—
+3K070138Cutera ER:Yag Laser HandpieceCutera, Inc.20071—
+3K063867Cutera ER:Ysgg Laser HandpieceCutera, Inc.20072—
+3K062369Iridex Oculight TXIridex Corp200673—
+3K062336Optimedica Laser Indirect OphthalmoscopeOptimedica Corporation20061—
+3K061025Accutech Endolite ProbeAccutech Medical Technologies, Inc.20061—
+3K051876Multiwave XRPacific Quantum Instruments, Inc.20050—
+3K050293Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP Plus ND: Yag Family of…Fotona D.D.2005200—
+3K041829Focus Medical Naturalase LP and Naturalight Family of ProductsFocus Medical, LLC20044—
+3K040384Mydon CWavelight Laser Technologie AG200451—
+3K033072Lucentlite, Model Imd 010Industrial & Medical Design, Inc.20040—
+3K033251The Friendlylight ND: Yag LasersInnotech USA, Inc.2004519—
+3K033172Candela Gentleyag Family of Laser SystemsCandela Corp.2003654—
+3K021180Candela Vbeam Pulsed Dye Laser SystemCandela Corp.2002318—
+4K260632Laser Thermal Therapy KitElesta S.P.A20260—
+4K250189AdvaTxAdvalight Aps20250—
+4K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+4K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+4K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+4K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+4K232117Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)Wuhan Lotuxs Technology Co., Ltd.20231—
+4K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+4K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+4K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+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—
+4K213594Echolaser X4Elesta S.P.A20221—
+4K210183Waterlase iPLusBiolase, Inc.20220—
+4K202288FinebeamSNJ Co., Ltd.20212—
+4K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+4K193367elysion-proHigh Technology Products S.L.U20203—
+4K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+4K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+4K180508Joule SystemSciton, Inc20183—
+4K173677InMode VLazeInmode MD, Ltd.20183—
+4K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+4K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+4K170179LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer InfinityLumenis, Ltd.201714—
+4K170850Alma QAlma Lasers, Ltd.20172—
+4K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+4K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+4K141237Harmony LiteAlma, Inc.20154—
+4K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+4K141555AdvantageLutronic Corporation201414—
+4K130256MDK Multi-Applications PlatformQuanta System Spa201338—
+4K122493GenesisplusCutera, Inc.201318—
+4K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+4K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—
+4K123168Q-Plus T+ Ipl Laser SystemQuanta System Spa2012401
+4K121508Lightwalker at Lightwalker DT Lightwalker ST-E Lightwalker ST-NFotona D.D.20121—
+4K123056Pascal Laser Indirect OphthalmoscopeTopcon Medical Laser Systems, Inc. (Tmls)20120—
+4K113843Freedom ND: Yag Laser SystemLutronic Corporation20120—
+4K120235Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag Lasers, Friendlylight Neo…Aerolase Medical Lasers, LLC201233—
+4K113115Epicare YagLight Age, Inc.20120—
+4K113702Fotona XP ND: Yag Laser SystemFotona D.D.201265—
+4K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+4K110364Dornier Medilas D Litebeam+ 1470Dornier Medtech America, Inc.20117—
+4K111483Joule Clearsense Laser SystemSciton, Inc20110—
+4K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—