510(k) Report

Devices descending from K042165

241 later devices reach Cutera Tabletop Aesthetic Product through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101916Joule Multi-Platform SystemSciton, Inc2011111—
+1K080318Alma Laser Nir ModuleAlma Lasers, Ltd.2008184—
+1K070388Profile Multi-Platform SystemSciton, Inc2007129—
+1K050069Cutera Flashlamp Tabletop Aesthetic ProductCutera, Inc.20050—
+2K213761Joule diVa SystemSciton, Inc20220—
+2K193656SkyPulseFotona D.O.O.202011—
+2K173285Joule SystemSciton, Inc20185—
+2K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+2K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+2K132976AdvatxAdvalight Aps20141—
+2K102716Modified Alma Lasers Family of Soprano XL Multi-Application PlatmformsAlma Lasers, Inc.2010124—
+2K101573Accusculpt II Laser SystemLutronic Corporation20101—
+2K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+2K083595EzlaseBiolase Technology, Inc.200958—
+2K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+2K081352Profile Multi-Platform SystemSciton, Inc2008112—
+2K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+2K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+2K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+3K250189AdvaTxAdvalight Aps20250—
+3K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+3K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+3K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+3K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+3K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+3K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+3K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+3K210183Waterlase iPLusBiolase, Inc.20220—
+3K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+3K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+3K193367elysion-proHigh Technology Products S.L.U20203—
+3K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+3K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+3K180508Joule SystemSciton, Inc20183—
+3K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+3K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+3K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+3K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+3K141237Harmony LiteAlma, Inc.20154—
+3K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+3K132989Speed 808 Diode Laser SystemBeijing Toplaser Technology Co., Ltd.20140—
+3K123971Cynosure 1064NM Diode LaserCynosure, Inc.201325—
+3K123257Emvera DioluxEmvera Technologies, Inc.20123—
+3K121286EPIC 10Biolase Technology, Inc.201231—
+3K112031Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for Use with the Family…Alma Lasers, Inc.2011118—
+3K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+3K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+4K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+4K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+4K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+4K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+4K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+4K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+4K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+4K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+4K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+4K230308Alma HarmonyAlma Lasers, Inc.20232—
+4K223680Eneka ProTermosalud20230—
+4K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+4K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+4K222369PURE LaserEndymed Medical, Ltd.20220—
+4K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+4K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+4K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+4K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+4K210847UltraClear Fractional Laser SystemFa International, LP20210—
+4K203728DarwinLuvo Medical Technologies, Inc.20211—
+4K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+4K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+4K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+4K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+4K192430Epic 980Biolase, Inc.20195—
+4K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+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—
+4K181019Diode Laser SystemGuangzhou Huafei Tongda Technology Co., Ltd.20186—
+4K180967Dental Diode Laser SystemLazon Medical Laser Co., Ltd.20180—
+4K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+4K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+4K171227StarWalkerFotona D.O.O.20177—
+4K170500SIROLaser Advance+Dentsply Sirona201721—
+4K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.20163—
+4K161198Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3Usa Laser Biotech, Inc.20160—
+4K160947LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX…Usa Laser Biotech, Inc.20160—
+4K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+4K153718Spirit Hair Removal laser FamilyActive Optical Systems, Ltd.20167—
+4K152898Diode Laser Therapy SystemsBeijing Sincoheren Science and Tech. Development Co., Ltd.20161—
+4K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+4K152714Quanta ForteQuanta System Spa201513—
+4K150724SculpSureCynosure, Inc.201521—
+4K150230SculpSureCynosure, Inc.201521—
+4K141986Elux 810 LaserEquipmed North America, Inc.20150—
+4K131838Diode Laser for Hiar RemovalBeijing Honkon Technologies Co., Ltd.20140—
+4K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+4K123483Diode LaserBeijing Syntech Laser CO., LTD.201353—
+4K101152Naturalase Diode Laser Family Naturalase Model NL980, Naturalase Diode Laser Family…Focus Medical, LLC20100—
+4K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+5K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.20260—
+5K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+5K252561BTL-754FFBTL Industries, Inc.20260—