510(k) Report

Devices descending from K050370

239 later devices reach Palomar Luxir Handpiece through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080318Alma Laser Nir ModuleAlma Lasers, Ltd.2008184—
+1K070298Modification to Palomar Luxir HandpiecePalomar Medical Technologies, Inc.200764—
+1K052647Clini-Lase System, Models CL-Base, CL-2000, CL-1200, CL-500, CL-300, CL-275, CL-155…American Spine Center, Ltd.20052—
+2K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+2K110907Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc.201157—
+2K103664Primus Aesthetic PlatformPalomar Medical Technologies, Inc.20117—
+2K102716Modified Alma Lasers Family of Soprano XL Multi-Application PlatmformsAlma Lasers, Inc.2010124—
+2K083595EzlaseBiolase Technology, Inc.200958—
+2K060134Apollo IR Heat Lamp SystemApollo Physical Therapy Products International200611
+3K233473Deka LotusEl.En S.P.A.20241—
+3K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+3K192856MT OneM&T S.R.L.20202—
+3K193367elysion-proHigh Technology Products S.L.U20203—
+3K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+3K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+3K173285Joule SystemSciton, Inc20185—
+3K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+3K153229SuperbiumBios S.R.L.20162—
+3K150466ZX2 Laser SystemLzr7, Inc.20150—
+3K141237Harmony LiteAlma, Inc.20154—
+3K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+3K142376Palomar Icon Aesthetic SystemCynosure, Inc.201413—
+3K132989Speed 808 Diode Laser SystemBeijing Toplaser Technology Co., Ltd.20140—
+3K130028Resurfx 1565NM Laser ModuleLumenis, Ltd.201341—
+3K123971Cynosure 1064NM Diode LaserCynosure, Inc.201325—
+3K123257Emvera DioluxEmvera Technologies, Inc.20123—
+3K121286EPIC 10Biolase Technology, Inc.201231—
+3K120622Palomar Vectus LaserPalomar Medical Technologies, Inc.20124—
+3K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+3K112031Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for Use with the Family…Alma Lasers, Inc.2011118—
+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—
+4K252561BTL-754FFBTL Industries, Inc.20260—
+4K250281Deka LotusEl.En S.P.A.20250—
+4K241270BTL-754BTL Industries, Inc.20251—
+4K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+4K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+4K230077LaserMENeauvia North America20232—
+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—
+4K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+4K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+4K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+4K203728DarwinLuvo Medical Technologies, Inc.20211—
+4K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+4K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+4K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+4K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+4K193426Elite iQCynosure, LLC20201—
+4K192430Epic 980Biolase, Inc.20195—
+4K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+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—
+4K180508Joule SystemSciton, Inc20183—
+4K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+4K163196ACTION II Laser SystemLutronic Corporation20170—
+4K170500SIROLaser Advance+Dentsply Sirona201721—
+4K162765Venus Velocity Diode Laser SystemVenus Concept, Ltd.20171—
+4K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.20163—
+4K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+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—
+4K153718Spirit Hair Removal laser FamilyActive Optical Systems, Ltd.20167—
+4K152898Diode Laser Therapy SystemsBeijing Sincoheren Science and Tech. Development Co., Ltd.20161—
+4K152714Quanta ForteQuanta System Spa201513—
+4K150724SculpSureCynosure, Inc.201521—
+4K150230SculpSureCynosure, Inc.201521—
+4K141986Elux 810 LaserEquipmed North America, Inc.20150—
+4K142860Lumenis M22 SystemLumenis, Ltd.2015381
+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—
+5K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.20260—
+5K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+5K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+5K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+5K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+5K242859VEGAIbramed Equipamentos Médicos20250—
+5K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+5K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+5K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+5K241656Eneka SelectifTermosalud20241—
+5K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+5K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+5K234057NirvanaEl.En S.P.A.20240—
+5K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+5K233024Alma HarmonyAlma Lasers, Inc.20241—
+5K232222Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)Medency S.R.L.20230—
+5K232236EchoQuanta System Spa20230—
+5K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+5K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+5K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+5K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+5K221571InMode Multi-systemInMode, Ltd.20222—
+5K210367D-Laser Blue, D-Laser 16Guilin Woodpecker Medical Instrument Co., Ltd.20226—