510(k) Report

Devices descending from K024179

308 later devices reach Palomar Lightcube through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K051961Wwmed, Model 401Wong Way Corporation20060—
+1K041885Bioflex LD-175 and LD-1200 Treatment HeadsMeditech International, Inc.20052—
+1K033768Altus Medical Optional Infrared HandpieceAltus Medical, Inc.2004294—
+1K032787Neurolase, Models 150V, 150C, 1064Spectrum Laser & Technologies200315—
+2K081355Bioflex LD-R100 Treatment HeadMeditech International, Inc.20080—
+2K080084Cell Gen Laser, Model CG-4000Cell Gen Therapeutics, LLC20081—
+2K080318Alma Laser Nir ModuleAlma Lasers, Ltd.2008184—
+2K060134Apollo IR Heat Lamp SystemApollo Physical Therapy Products International200611
+2K051875Bioflex Prescription System and Related Treatment HeadsMeditech International, Inc.20061—
+2K053201Curae'lase CL1000 IR Laser SystemCurae'Lase, Inc.20050—
+2K050370Palomar Luxir HandpiecePalomar Medical Technologies, Inc.2005239—
+2K042165Cutera Tabletop Aesthetic ProductCutera, Inc.20042411
+2K033986MLT-1000 IR Laser SystemMedical Laser Therapeutics LP200410—
+3K213524CytonPro-5000Cytonsys, Inc.20220—
+3K150466ZX2 Laser SystemLzr7, Inc.20150—
+3K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+3K101916Joule Multi-Platform SystemSciton, Inc2011111—
+3K102716Modified Alma Lasers Family of Soprano XL Multi-Application PlatmformsAlma Lasers, Inc.2010124—
+3K083595EzlaseBiolase Technology, Inc.200958—
+3K070298Modification to Palomar Luxir HandpiecePalomar Medical Technologies, Inc.200764—
+3K070388Profile Multi-Platform SystemSciton, Inc2007129—
+3K053473Maestro MDTL Laser SystemAdvanced Medical Technologies, Inc.20068—
+3K052647Clini-Lase System, Models CL-Base, CL-2000, CL-1200, CL-500, CL-300, CL-275, CL-155…American Spine Center, Ltd.20052—
+3K050069Cutera Flashlamp Tabletop Aesthetic ProductCutera, Inc.20050—
+4K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+4K213761Joule diVa SystemSciton, Inc20220—
+4K193656SkyPulseFotona D.O.O.202011—
+4K193367elysion-proHigh Technology Products S.L.U20203—
+4K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+4K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+4K173285Joule SystemSciton, Inc20185—
+4K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+4K141237Harmony LiteAlma, Inc.20154—
+4K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+4K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+4K132976AdvatxAdvalight Aps20141—
+4K132989Speed 808 Diode Laser SystemBeijing Toplaser Technology Co., Ltd.20140—
+4K123971Cynosure 1064NM Diode LaserCynosure, Inc.201325—
+4K123257Emvera DioluxEmvera Technologies, Inc.20123—
+4K121286EPIC 10Biolase Technology, Inc.201231—
+4K112031Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for Use with the Family…Alma Lasers, Inc.2011118—
+4K110907Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc.201157—
+4K103664Primus Aesthetic PlatformPalomar Medical Technologies, Inc.20117—
+4K101573Accusculpt II Laser SystemLutronic Corporation20101—
+4K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+4K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+4K082969Luminex Infrared Lamp SystemMedical Laser Systems, Inc.20081—
+4K081352Profile Multi-Platform SystemSciton, Inc2008112—
+4K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+4K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+4K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+4K061656Laser-D68Laser Pain Clinics LP20065—
+5K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+5K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+5K250189AdvaTxAdvalight Aps20250—
+5K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+5K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+5K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+5K233473Deka LotusEl.En S.P.A.20241—
+5K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+5K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+5K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+5K230308Alma HarmonyAlma Lasers, Inc.20232—
+5K223680Eneka ProTermosalud20230—
+5K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+5K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+5K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+5K222369PURE LaserEndymed Medical, Ltd.20220—
+5K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+5K210183Waterlase iPLusBiolase, Inc.20220—
+5K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+5K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+5K203728DarwinLuvo Medical Technologies, Inc.20211—
+5K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+5K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+5K192856MT OneM&T S.R.L.20202—
+5K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+5K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+5K192430Epic 980Biolase, Inc.20195—
+5K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+5K181019Diode Laser SystemGuangzhou Huafei Tongda Technology Co., Ltd.20186—
+5K180967Dental Diode Laser SystemLazon Medical Laser Co., Ltd.20180—
+5K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+5K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+5K180508Joule SystemSciton, Inc20183—
+5K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+5K170500SIROLaser Advance+Dentsply Sirona201721—
+5K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.20163—
+5K161198Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3Usa Laser Biotech, 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—
+5K153229SuperbiumBios S.R.L.20162—
+5K153718Spirit Hair Removal laser FamilyActive Optical Systems, Ltd.20167—
+5K152898Diode Laser Therapy SystemsBeijing Sincoheren Science and Tech. Development Co., Ltd.20161—
+5K152714Quanta ForteQuanta System Spa201513—
+5K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+5K150724SculpSureCynosure, Inc.201521—
+5K150230SculpSureCynosure, Inc.201521—
+5K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+5K141986Elux 810 LaserEquipmed North America, Inc.20150—
+5K142376Palomar Icon Aesthetic SystemCynosure, Inc.201413—