510(k) Report

Devices descending from K971737

1,000 later devices reach Cynosure Photogenica Lpir Dermatological Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K990119Epi-Star Surgical Laser SysterNidek, Inc.200050—
+1K991798Acme Medical Aesthetic ND:Yag LaserAltus Medical2000745—
+1K993671Candela Sclero Long Pulse Dye LaserCandela Corp.2000700—
+1K992298Iriderm, Model Apex 800Iridex Corp1999175—
+1K990043Smoothlase Alexandrite Laser SystemLeisegang Medical, Inc.19990—
+1K984601Candela Gentlelase II Dermatological LaserCandela Corp.1999110—
+1K981351Candela Gentlelase GL Dermatological LaserCandela Corp.1998811—
+1K980710Schwartz Electro-Optics, Inc. Crystalase 755 DP Alexandrite Laser SystemSchwartz Electro-Optics, Inc.19980—
+2K111144Candela Gentlelase Family of LasersCandela Corp.201191—
+2K032218Adept 1064/532/755 LaserAdept Medical Concepts2003104—
+2K032221Adept 1064/755 LaserAdept Medical Concepts20030—
+2K032220Adept 1064/532 LaserAdept Medical Concepts2003126—
+2K023881Profile 1064 Laser SystemSciton, Inc2003227—
+2K030508Depilase Trio Lase Laser SystemDepilase Group, Ltd.20030—
+2K022226Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future…Altus Medical, Inc.2002665—
+2K021650Athoscan for the Athos Laser Constans Cooling Hand Piece for the Athos LaserQuantel Medical20020—
+2K014040Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide I, II and…Altus Medical, Inc.2002739—
+2K020849Apex 800 Laser System, Model Apex 800Iridex Corp2002174—
+2K020697Depilase Twin Yag Laser SystemDepilase Group, Ltd.2002229—
+2K020463Depilase Yag Lase Plus Laser SystemDepilase Group, Ltd.20021—
+2K020412Depilase Twin Lase Laser SystemDepilase Group, Ltd.2002106—
+2K013748Candela Sclero Long Pulse Laser (Aka Vbeam)Candela Corp.2002699—
+2K013864Modification to Epi-Star Surgical Laser System, M0DEL DS-60Nidek, Inc.200249—
+2K994116Laser System Mediostar H (with and Without Skin Cooling System)Aesculap-Meditec North America20000—
+2K994260Candela Gentlelase GL Dermatological LaserCandela Corp.2000258—
+3K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+3K213350mJOULE System and AccessoriesSciton, Inc20220—
+3K161503ORIONYerim Engineering Co., Ltd.20161—
+3K151337StrialiteCentre Light Solutions, LLC20160—
+3K133319ET Lightsheer 1060, High Speed Lightsheer 1060Lumenis, Ltd.201424—
+3K112715Candela Gentlemax Family of LasersCandela Corp.201190—
+3K110370Q-ClearLight Age, Inc.201135—
+3K103626Cutera Genesisplus Laser SystemCutera, Inc.2011121—
+3K101916Joule Multi-Platform SystemSciton, Inc2011111—
+3K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198—
+3K083207Ultrawave Iii EX 1320Quanta System Spa2008961
+3K053527Spectra Hair Removal LaserSpectragenics, Inc.2008169—
+3K063828Diomed Delta 25Diomed, Ltd.20075—
+3K062369Iridex Oculight TXIridex Corp200673—
+3K060033Profile Multi-Platform SystemSciton, Inc2006221—
+3K052848Spectra Hair Removal LaserSpectragenics, Inc.2005172—
+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—
+3K042474ARIONWavelight Laser Technologie AG2004114—
+3K041262Duralite-GLLaser Scientific20040—
+3K040384Mydon CWavelight Laser Technologie AG200451—
+3K040727CRYO 5Zimmer Elektromedizin GmbH200448—
+3K033072Lucentlite, Model Imd 010Industrial & Medical Design, Inc.20040—
+3K033251The Friendlylight ND: Yag LasersInnotech USA, Inc.2004519—
+3K032846Spectra Pulsed Diode Laser, Model DR-1Spectragenics, Inc.2003173—
+3K031828Naturalase LP ND:Yag LaserFocus Medical, LLC20035—
+3K024371Candela Gentle Lase Family of Laser SystemCandela Corp.2003207—
+3K024260Candela Gentlelase Family of Laser SystemsCandela Corp.20031861
+3K022923Candela Gentle Yag Laser SystemCandela Corp.2003656—
+3K024335Candela Gentlelase Family of Laser SystemsCandela Corp.20031871
+3K023193Candela Gentle Yag Laser SystemCandela Corp.2002656—
+3K021180Candela Vbeam Pulsed Dye Laser SystemCandela Corp.2002318—
+4K232117Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)Wuhan Lotuxs Technology Co., Ltd.20231—
+4K213761Joule diVa SystemSciton, Inc20220—
+4K193656SkyPulseFotona D.O.O.202011—
+4K180224Element-TLElemenic Co., Ltd.20180—
+4K173677InMode VLazeInmode MD, Ltd.20183—
+4K173285Joule SystemSciton, Inc20185—
+4K170179LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer InfinityLumenis, Ltd.201714—
+4K170850Alma QAlma Lasers, Ltd.20172—
+4K143666Noblex Long Pulse Alexandrite LaserFinemec Co., Ltd.20150—
+4K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+4K141975Waterlase Iplus SBiolase, Inc.20150—
+4K141555AdvantageLutronic Corporation201414—
+4K140249Long Pulse ND: Yag Laser SystemAdvanced Technology Laser Co., Ltd.20143—
+4K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+4K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+4K132976AdvatxAdvalight Aps20141—
+4K133283Candela Gentlemax Family of Laser SystemsCandela Corp.201313—
+4K132185Family of Coolglide Aesthetic LasersCutera, Inc.201336—
+4K131095Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa201317—
+4K130199Clarity LPC Laser SystemLutronic Corporation20135—
+4K130256MDK Multi-Applications PlatformQuanta System Spa201338—
+4K122493GenesisplusCutera, Inc.201318—
+4K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+4K122368Waterlase Iplus All Tissue LaserBiolase Technology, 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—
+4K113843Freedom ND: Yag Laser SystemLutronic Corporation20120—
+4K120235Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag Lasers, Friendlylight Neo…Aerolase Medical Lasers, LLC201233—
+4K113702Fotona XP ND: Yag Laser SystemFotona D.D.201265—
+4K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+4K111483Joule Clearsense Laser SystemSciton, Inc20110—
+4K101306SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP Spectro, Models…Fotona D.D.201178—
+4K102954Cutera Qswitch Laser SystemCutera, Inc.201149—
+4K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc.2010921
+4K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+4K093162Fidelis Plus Iii D, at Fidelis D, Powerlase at D / Fidelis Plus Iii, at Fidelis…Fotona D.D.201083—
+4K090820Tria Hair Removal Laser SystemSpectragenics, Inc.2009167—
+4K091534Lightlas Model 532Lightmed Corp.200972—
+4K090762LEDAQuantel Derma GmbH200946—
+4K090571Alma Lasers ALEX755 ModuleAlma Lasers, Ltd.200958—
+4K090618Cynosure Smartcool Family Cold Air Device: Smartcool, Smartcool 6 and Cryo CCynosure, Inc.20090—
+4K081352Profile Multi-Platform SystemSciton, Inc2008112—