510(k) Report

Devices descending from K024064

681 later devices reach Polaris DS through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K092191Exilis, Model 5000Btl Industries, Ltd.200912—
+4K090762LEDAQuantel Derma GmbH200946—
+4K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+4K083590Iskra Medical Green Irf PrestigeIskra Medical, D.O.O.200913—
+4K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+4K082622Alma Lasers Accent B-Shape Massager Handpiece/ModuleAlma Lasers, Ltd.200945—
+4K083682180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc.2009121—
+4K082938EzlaseBiolase Technology, Inc.200850—
+4K081352Profile Multi-Platform SystemSciton, Inc2008112—
+4K082445CURATIVE980 Diode LaserOroscience, Inc.20080—
+4K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+4K081015Ceralas D 980NM Diode Laser, Models D15 and D25Biolitec, Inc.200834—
+4K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+4K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+4K073322Fox 1-980, Fox Q-1064, Fox-Q-810A.R.C Laser GmbH200822—
+4K072699Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models: Accent, Accent XLAlma Lasers, Ltd.200784—
+4K060448Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd.2006297—
+5K261964Echolaser X4Elesta S.P.A20260—
+5K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+5K260153Q-Switched Nd: YAG Laser System (Glamor Q)Nanjing Bestview Laser S&T Co., Ltd.20260—
+5K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+5K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+5K250165PastelleWontech Co., Ltd.20250—
+5K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+5K250722Nd: YAG Laser Therapy System (QN-1)Hebei JT Medical Co., Ltd.20250—
+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—
+5K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—
+5K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+5K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+5K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+5K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+5K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+5K222556BTL-785XBTL Industries, Inc.20235—
+5K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+5K222701MANTA LaserSqualus Med, Ltd.20222—
+5K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+5K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+5K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+5K221571InMode Multi-systemInMode, Ltd.20222—
+5K210183Waterlase iPLusBiolase, Inc.20220—
+5K211639BTL-785WBTL Industries, Inc.20227—
+5K210847UltraClear Fractional Laser SystemFa International, LP20210—
+5K202288FinebeamSNJ Co., Ltd.20212—
+5K212607DarwinLuvo Medical Technologies, Inc.20210—
+5K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+5K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+5K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+5K193201BTL-785FBtl20208—
+5K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+5K200104OxylightRaja Trading Company, Inc.202024—
+5K193367elysion-proHigh Technology Products S.L.U20203—
+5K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+5K191942MT One DiamondM&T S.R.L.20191—
+5K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+5K180359BTL-FR2000BTL Industries, Inc.20189—
+5K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+5K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+5K173692D-Actor 200 Vibration Massage SystemStorz Medical AG20186—
+5K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+5K173759Thermage CPT System and AccessoriesSolta Medical201821
+5K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+5K170758Thermage FLX System and AccessoriesSolta Medical201713—
+5K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+5K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+5K160312Fraxis DuoIlooda Co,., Ltd.201614—
+5K160075Accent XLAlma Lasers, Inc.20160—
+5K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+5K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+5K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+5K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+5K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+5K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+5K151629Guardian 1000Quanta System Spa20150—
+5K151655CO2RE SystemSyneron Medical, Ltd.20151—
+5K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+5K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+5K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+5K142860Lumenis M22 SystemLumenis, Ltd.2015381
+5K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+5K142910Legacy BXVenus Concept USA, Inc.201411—
+5K142093V20 SystemViora, Ltd.201432—
+5K140727Cutera Picosecond Laser SystemCutera, Inc.201447—
+5K140120EPIC 10Biolase, Inc.20141—
+5K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+5K133945Cutera Picosecond Laser SystemCutera, Inc.201414—
+5K133364Picosure WorkstationCynosure, Inc.201451—
+5K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+5K131757Tattoostar Effect ComboAsclepion Laser Technologies GmbH20140—
+5K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+5K140629Venus Swan (MP)2Venus Concept, Ltd.20140—
+5K140255Stop U (Packed Black Usa); Stop U (Packed White Usa)Pollogen, Ltd.20147—
+5K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+5K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+5K131095Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa201317—
+5K131059Pioneer Elite Diode LaserCAO Group, Inc.20132—
+5K123443Precise SHP Diode LaserCAO Group, Inc.20139—
+5K120510TranscendSyneron Medical, Ltd.201318—
+5K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—