510(k) Report

Devices descending from K912703

728 later devices reach Optica 60 ND;Yag Surgical Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K973764Temperature Diagnostic AccessoryNew Star Lasers, Inc.19970—
+1K962791New Star Model 130 6-Watt ND: Yag Laser SystemNew Star Lasers, Inc.1997726—
+2K023734Aramis II Dermatological LaserQuantel Medical2003317—
+2K022817Cooltouch ND:Yag Laser System, Model Cooltouch, Cooltouch-II ND:Yag Laser System, Model…Icn Pharmaceuticals, Inc.2002575—
+2K014035Cooltouch and Cooltouch-II ND:Yag Laser SystemsCooltouch Corp.2002668—
+3K252561BTL-754FFBTL Industries, Inc.20260—
+3K040617Reliant Laser System IIReliant Technologies, Inc.2004316—
+3K033072Lucentlite, Model Imd 010Industrial & Medical Design, Inc.20040—
+3K032459Profile 1320 Laser SystemSciton, Inc2004518—
+3K030846Candela Smoothbeam Laser SystemCandela Corp.20033171
+3K022466Profile 1320 Laser SystemSciton, Inc2002520—
+3K022226Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future…Altus Medical, Inc.2002665—
+4K133319ET Lightsheer 1060, High Speed Lightsheer 1060Lumenis, Ltd.201424—
+4K130459Tria Fan SystemTria Beauty, Inc.20131—
+4K110370Q-ClearLight Age, Inc.201135—
+4K103626Cutera Genesisplus Laser SystemCutera, Inc.2011121—
+4K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+4K071051Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007194—
+4K063038Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007195—
+4K060310Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc.2006230—
+4K060033Profile Multi-Platform SystemSciton, Inc2006221—
+4K050293Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP Plus ND: Yag Family of…Fotona D.D.2005200—
+4K042319Reliant Laser II System and AccessoriesReliant Technologies, Inc.2005284—
+4K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd.2004517—
+4K033251The Friendlylight ND: Yag LasersInnotech USA, Inc.2004519—
+4K032218Adept 1064/532/755 LaserAdept Medical Concepts2003104—
+4K032221Adept 1064/755 LaserAdept Medical Concepts20030—
+4K032220Adept 1064/532 LaserAdept Medical Concepts2003126—
+4K031828Naturalase LP ND:Yag LaserFocus Medical, LLC20035—
+4K023881Profile 1064 Laser SystemSciton, Inc2003227—
+5K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+5K232117Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)Wuhan Lotuxs Technology Co., Ltd.20231—
+5K213761Joule diVa SystemSciton, Inc20220—
+5K213350mJOULE System and AccessoriesSciton, Inc20220—
+5K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+5K173677InMode VLazeInmode MD, Ltd.20183—
+5K170179LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer InfinityLumenis, Ltd.201714—
+5K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+5K141975Waterlase Iplus SBiolase, Inc.20150—
+5K141868Tria FanpTria Beauty, Inc.20140—
+5K141555AdvantageLutronic Corporation201414—
+5K122493GenesisplusCutera, Inc.201318—
+5K122368Waterlase Iplus All Tissue LaserBiolase Technology, Inc.20130—
+5K121508Lightwalker at Lightwalker DT Lightwalker ST-E Lightwalker ST-NFotona D.D.20121—
+5K113843Freedom ND: Yag Laser SystemLutronic Corporation20120—
+5K120235Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag Lasers, Friendlylight Neo…Aerolase Medical Lasers, LLC201233—
+5K113702Fotona XP ND: Yag Laser SystemFotona D.D.201265—
+5K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+5K111483Joule Clearsense Laser SystemSciton, Inc20110—
+5K101306SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP Spectro, Models…Fotona D.D.201178—
+5K101916Joule Multi-Platform SystemSciton, Inc2011111—
+5K101321Ematrix CO2Syneron Medical, Ltd.20102—
+5K101490Fraxel RE:Store Dual Laser System: Model, MC-Sys-SR1500-D-USThermage, Inc.2010282
+5K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+5K093162Fidelis Plus Iii D, at Fidelis D, Powerlase at D / Fidelis Plus Iii, at Fidelis…Fotona D.D.201083—
+5K083207Ultrawave Iii EX 1320Quanta System Spa2008961
+5K073572Matrix RF ApplicatorSyneron Medical, Ltd.2008102—
+5K082028Laserpeel Soft-Met Modified Erbium LaserGlobal USA Distribution, LLC20080—
+5K080496Mosaic ECO2 Laser SystemLutronic Corporation200830—
+5K080915Fraxel RE:Pair (Fraxel Iii SR) Laser System and AccessoriesReliant Technologies, Inc.2008187—
+5K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+5K080244Palomar Lux 1540 HandpiecePalomar Medical Products, Inc.2008161—
+5K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008266—
+5K070355Fotona Fidelis Iii ER:Yag/ND:Yag Laser System FamilyFotona D.D.2008194—
+5K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc.2008202—
+5K072344Apl Medical SystemBios S.R.L.20076—
+5K063427Lumina Intense Pulsed Light (& Laser) SystemLynton Lasers Limited20070—
+5K070392Mosaic Laser SystemLutronic Corporation20078—
+5K070284Fralex SR 1500 Laser System (Fralex II SR Laser System)Reliant Technologies, Inc.2007172—
+5K070388Profile Multi-Platform SystemSciton, Inc2007129—
+5K070138Cutera ER:Yag Laser HandpieceCutera, Inc.20071—
+5K063867Cutera ER:Ysgg Laser HandpieceCutera, Inc.20072—
+5K061652Palomar LUX1540 HandpiecePalomar Medical Products, Inc.2007259—
+5K063571Palomar LUX2940 HandpiecePalomar Medical Technologies, Inc.2007160—
+5K062303Fraxel II SR Laser SystemReliant Technologies, Inc.2007226—
+5K063828Diomed Delta 25Diomed, Ltd.20075—
+5K062369Iridex Oculight TXIridex Corp200673—
+5K052354Oculase MDBiolase Technology, Inc.20065—
+5K051876Multiwave XRPacific Quantum Instruments, Inc.20050—
+5K051359Candela Family of Pulsed Dye Laser Systems: Pigmented Lesion Handpiece AccessoryCandela Corp.200511
+5K041829Focus Medical Naturalase LP and Naturalight Family of ProductsFocus Medical, LLC20044—
+5K040384Mydon CWavelight Laser Technologie AG200451—
+6K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+6K243630Medical Laser System Incanto / Evoline Platinum /EvolineSolar LS Cjsc20250—
+6K233024Alma HarmonyAlma Lasers, Inc.20241—
+6K231910DermRays ReviveWuhan Lotuxs Technology Co., Ltd.20240—
+6K232236EchoQuanta System Spa20230—
+6K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+6K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+6K230308Alma HarmonyAlma Lasers, Inc.20232—
+6K220214Painless IPL System - KDT750Shanghai Omni Laser Skinology Co., Ltd.20230—
+6K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+6K221571InMode Multi-systemInMode, Ltd.20222—
+6K213261EpilMENeauvia North America20220—
+6K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+6K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+6K192856MT OneM&T S.R.L.20202—
+6K193656SkyPulseFotona D.O.O.202011—
+6K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+6K193367elysion-proHigh Technology Products S.L.U20203—