510(k) Report

Devices descending from K003538

447 later devices reach TDP CQ-27 Heat Lamp through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K123971Cynosure 1064NM Diode LaserCynosure, Inc.201325—
+4K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc.20123—
+4K111501I-Lipo SystemChromogenex Technologies Limited201215—
+4K101916Joule Multi-Platform SystemSciton, Inc2011111—
+4K102716Modified Alma Lasers Family of Soprano XL Multi-Application PlatmformsAlma Lasers, Inc.2010124—
+4K083595EzlaseBiolase Technology, Inc.200958—
+4K070298Modification to Palomar Luxir HandpiecePalomar Medical Technologies, Inc.200764—
+4K070388Profile Multi-Platform SystemSciton, Inc2007129—
+4K053473Maestro MDTL Laser SystemAdvanced Medical Technologies, Inc.20068—
+4K052647Clini-Lase System, Models CL-Base, CL-2000, CL-1200, CL-500, CL-300, CL-275, CL-155…American Spine Center, Ltd.20052—
+4K050069Cutera Flashlamp Tabletop Aesthetic ProductCutera, Inc.20050—
+5K253504Volnewmer™Classys, Inc.20260—
+5K253480Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L.20260—
+5K252845Venus Nova (FP-2001)Venus Concept, Inc.20250—
+5K250065DENSITY; DENZA; DENSITY NoirJeisys Medical Incorporated20250—
+5K251632Optimas MAX SystemInMode, Ltd.20251—
+5K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+5K240897CellinewVIOL Co., Ltd.20240—
+5K240991eMVFit (MVF-10M)Weero Co., Ltd.20240—
+5K233962ReBorn (1050nm)Lightfective, Ltd.20240—
+5K240313Oligio XWontech Co., Ltd.20241—
+5K231495The Evolve System with the Transform ApplicatorInMode, Ltd.20231—
+5K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+5K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+5K213761Joule diVa SystemSciton, Inc20220—
+5K220592Venus BlissMAXVenus Concept USA, Inc.20221—
+5K213308Venus BlissMAXVenus Concept USA, Inc.20222—
+5K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+5K211461Family of Venus RF Systems - Venus FreedomVenus Concept USA, Inc.20210—
+5K210877Evolve System with the T3 ApplicatorInMode, Ltd.20215—
+5K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd.20216—
+5K201475Ultimate Contour, Ultimate Contour MiniCAO Group, Inc.20200—
+5K193656SkyPulseFotona D.O.O.202011—
+5K193367elysion-proHigh Technology Products S.L.U20203—
+5K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+5K192224BTL-899Btl20198—
+5K191855EmFace DeviceInmode MD, Ltd.20191—
+5K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+5K181095RF-ReliefEl Global Trade, Ltd.20181—
+5K180709truSculpt RF Device; truSculpt; truSculpt 3DCutera, Inc.20183—
+5K173285Joule SystemSciton, Inc20185—
+5K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+5K172302InMode PLUS SystemInmode MD, Ltd.201713—
+5K172004truSculptCutera, Inc.20173—
+5K161198Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3Usa Laser Biotech, Inc.20160—
+5K152731XP1100 RFBTL Industries, Inc.20160—
+5K160947LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX…Usa Laser Biotech, Inc.20160—
+5K150724SculpSureCynosure, Inc.201521—
+5K150230SculpSureCynosure, Inc.201521—
+5K143741Lipofina Laser SystemYolo Medical, Inc.20153—
+5K141237Harmony LiteAlma, Inc.20154—
+5K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+5K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+5K132976AdvatxAdvalight Aps20141—
+5K132989Speed 808 Diode Laser SystemBeijing Toplaser Technology Co., Ltd.20140—
+5K130341Strawberry, Strawberry & CreamLaser Lipo Limited201312—
+5K123257Emvera DioluxEmvera Technologies, Inc.20123—
+5K121286EPIC 10Biolase Technology, Inc.201231—
+5K112031Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for Use with the Family…Alma Lasers, Inc.2011118—
+5K110907Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc.201157—
+5K103664Primus Aesthetic PlatformPalomar Medical Technologies, Inc.20117—
+5K101573Accusculpt II Laser SystemLutronic Corporation20101—
+5K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+5K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+5K082969Luminex Infrared Lamp SystemMedical Laser Systems, Inc.20081—
+5K081352Profile Multi-Platform SystemSciton, Inc2008112—
+5K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+5K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+5K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+5K061656Laser-D68Laser Pain Clinics LP20065—
+6K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+6K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+6K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+6K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+6K250734OptiLUV DevicePollogen, Ltd.20250—
+6K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+6K241433EVE Synergy (EVE-20M)Weero Co., Ltd.20251—
+6K250189AdvaTxAdvalight Aps20250—
+6K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+6K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+6K250200InbellaBody SystemInbella Medical, Inc.20250—
+6K243139Reverso Pro SystemIndiba S. A. U.20250—
+6K243929Oligio XWontech Co., Ltd.20250—
+6K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+6K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+6K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+6K233473Deka LotusEl.En S.P.A.20241—
+6K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+6K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+6K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+6K230167BACK 4Swims America Corp20230—
+6K230037BACK 3Swims America Corp20230—
+6K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+6K230308Alma HarmonyAlma Lasers, Inc.20232—
+6K223680Eneka ProTermosalud20230—
+6K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+6K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+6K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+6K222369PURE LaserEndymed Medical, Ltd.20220—
+6K221407truSculpt iDCutera, Inc.20222—