510(k) Report

Devices descending from K080121

196 later devices reach Cynosure Smartlipo Multiwavlength Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+1K090126Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP Changer,Model…Fotona D.D.200980—
+1K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+1K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+1K081352Profile Multi-Platform SystemSciton, Inc2008112—
+1K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+2K202288FinebeamSNJ Co., Ltd.20212—
+2K173285Joule SystemSciton, Inc20185—
+2K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+2K132286Hyperion Long Pulsed ND: Yag LaserScarlet Rf, Inc.20143—
+2K121508Lightwalker at Lightwalker DT Lightwalker ST-E Lightwalker ST-NFotona D.D.20121—
+2K120235Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag Lasers, Friendlylight Neo…Aerolase Medical Lasers, LLC201233—
+2K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+2K101306SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP Spectro, Models…Fotona D.D.201178—
+2K101916Joule Multi-Platform SystemSciton, Inc2011111—
+2K100558Quanta Diode Laser SystemQuanta System Spa201068—
+2K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+2K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+3K261964Echolaser X4Elesta S.P.A20260—
+3K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+3K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+3K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+3K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—
+3K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+3K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+3K222701MANTA LaserSqualus Med, Ltd.20222—
+3K213761Joule diVa SystemSciton, Inc20220—
+3K193656SkyPulseFotona D.O.O.202011—
+3K182930PerioLase Nd:YAG Pulsed Dental Laser SystemMillennium Dental Technologies, Inc.20190—
+3K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+3K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+3K180508Joule SystemSciton, Inc20183—
+3K171227StarWalkerFotona D.O.O.20177—
+3K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+3K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+3K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+3K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+3K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+3K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+3K150140MCL 31 DermablateAsclepion Laser Technologies GmbH20157—
+3K140120EPIC 10Biolase, Inc.20141—
+3K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+3K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+3K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+3K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+3K132976AdvatxAdvalight Aps20141—
+3K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+3K121327Diolase 10SBiolase Technology, Inc.20132—
+3K120437Twister Side-Fire Fiber Optic Delivery SystemBiolitec Sia (Latvia)20120—
+3K120231Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual)Biolitec Medical Devices, Inc.20124—
+3K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc.201046—
+3K101152Naturalase Diode Laser Family Naturalase Model NL980, Naturalase Diode Laser Family…Focus Medical, LLC20100—
+3K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+4K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+4K252561BTL-754FFBTL Industries, Inc.20260—
+4K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+4K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+4K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+4K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+4K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+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—
+4K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+4K233344Regenalase Laser SystemIpg Medical20240—
+4K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+4K231054V-LaserWontech Co., Ltd.20231—
+4K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+4K223540AvalancheLase FamilyFotona D.O.O.20230—
+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—
+4K213267Dynamis Pro FamilyFotona D.O.O.20222—
+4K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+4K210183Waterlase iPLusBiolase, Inc.20220—
+4K213350mJOULE System and AccessoriesSciton, Inc20220—
+4K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+4K210847UltraClear Fractional Laser SystemFa International, LP20210—
+4K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+4K203788DermaV Laser SystemLutronic Corporation202101
+4K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+4K202172StarWalkerFotona D.O.O.20203—
+4K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+4K193367elysion-proHigh Technology Products S.L.U20203—
+4K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+4K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+4K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+4K183156V-LaserWontech Co., Ltd.20193—
+4K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+4K181518Sebacia MicroparticlesSebacia, Inc.20180—
+4K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+4K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+4K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+4K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+4K163196ACTION II Laser SystemLutronic Corporation20170—
+4K161185LUCERNA Dental LaserViax Dental Lab20160—
+4K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+4K152737Lite TouchFocus Medical, LLC20160—
+4K153229SuperbiumBios S.R.L.20162—
+4K141237Harmony LiteAlma, Inc.20154—
+4K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—