510(k) Report

Devices descending from K031671

678 later devices reach Polaris WR through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+1K100586Venus Freeze SystemVenus Concept, Ltd.201031—
+1K083461Imagine TC Skin Therapy SystemEndymion Medical, Ltd.2009101—
+1K070388Profile Multi-Platform SystemSciton, Inc2007129—
+1K070004AccentAlma Lasers, Ltd.2007181—
+1K053616Polaris WR, ST ApplicatorSyneron Medical, Ltd.2006133—
+1K051214Aluma Skin Renewal SystemLumenis, Inc.2005476—
+1K041959Polaris DS/CometSyneron Medical, Ltd.2004301—
+2K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+2K192621Medical RFTriworks Group Srl20200—
+2K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+2K140926Inmode Wmface DeviceInmode MD, Ltd.20143—
+2K133405MinnieElettronica Valseriana Srl20140—
+2K130501IntensifEndymed Medical, Ltd.201457—
+2K132431Thermage CPT SystemSolta Medical, Inc.2013171
+2K130793Newa Skin Therapy SystemEndymion Medical, Ltd.20130—
+2K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc.20123—
+2K112669Tattoostar Effect YAsclepion Laser Technologies GmbH20128—
+2K120513Glow by EndymedEndymed Medical, Ltd.20125—
+2K111670Venus Freeze (MP)2 SystemVenus Concept, Ltd.201213—
+2K111026ApolloPollogen, Ltd.201114—
+2K111784Venus Swan SystemVenus Concept, Ltd.20111—
+2K110672Etwo Skin Treatment SystemSyneron, Ltd.20112—
+2K101916Joule Multi-Platform SystemSciton, Inc2011111—
+2K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd.201164—
+2K101147Modified Alma Lasers Family of Accent Radiofrequency (RF) SystemAlma Lasers, Inc.20114—
+2K101573Accusculpt II Laser SystemLutronic Corporation20101—
+2K101967Non-Ablative Wrinkle Treatent Handpiece Modle Pelleve'Ellman Int'L, Inc.201053—
+2K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+2K090025Matrix RF ApplicatorSyneron Medical, Ltd.201018—
+2K092191Exilis, Model 5000Btl Industries, Ltd.200912—
+2K083590Iskra Medical Green Irf PrestigeIskra Medical, D.O.O.200913—
+2K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+2K082622Alma Lasers Accent B-Shape Massager Handpiece/ModuleAlma Lasers, Ltd.200945—
+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—
+2K072699Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models: Accent, Accent XLAlma Lasers, Ltd.200784—
+2K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are…Intermedic Arfran, SA2006299—
+2K060448Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd.2006297—
+3K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+3K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+3K222556BTL-785XBTL Industries, Inc.20235—
+3K213761Joule diVa SystemSciton, Inc20220—
+3K221571InMode Multi-systemInMode, Ltd.20222—
+3K211639BTL-785WBTL Industries, Inc.20227—
+3K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+3K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+3K193201BTL-785FBtl20208—
+3K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+3K193656SkyPulseFotona D.O.O.202011—
+3K180359BTL-FR2000BTL Industries, Inc.20189—
+3K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+3K173692D-Actor 200 Vibration Massage SystemStorz Medical AG20186—
+3K173285Joule SystemSciton, Inc20185—
+3K173759Thermage CPT System and AccessoriesSolta Medical201821
+3K170758Thermage FLX System and AccessoriesSolta Medical201713—
+3K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+3K160312Fraxis DuoIlooda Co,., Ltd.201614—
+3K160075Accent XLAlma Lasers, Inc.20160—
+3K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+3K142860Lumenis M22 SystemLumenis, Ltd.2015381
+3K142910Legacy BXVenus Concept USA, Inc.201411—
+3K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+3K131757Tattoostar Effect ComboAsclepion Laser Technologies GmbH20140—
+3K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+3K140629Venus Swan (MP)2Venus Concept, Ltd.20140—
+3K140255Stop U (Packed Black Usa); Stop U (Packed White Usa)Pollogen, Ltd.20147—
+3K132976AdvatxAdvalight Aps20141—
+3K120510TranscendSyneron Medical, Ltd.201318—
+3K122966XP200Btl Industries, Ltd.20131—
+3K102698Pelleve Glidesafe Non-Ablative Wrinkle Treatment System Model Pelleve GlidesafeEllman Int'L, Inc.201139—
+3K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+3K102368Non-Ablative Wrinkle Treatment HandpieceEllman Int'L, Inc.201052—
+3K093465Fusion SystemEclipsemed Global, Inc.20100—
+3K092195Cutera Multimodal Cellulite Product (Cmmcd)Cutera, Inc.20090—
+3K090580Thermage Thermacool NXT System and AccessoriesSolta Medical, Inc.200919—
+3K091323Modified Intermedic Diode Laser 980NM System (Multidiode SST 200)Intermedic Arfran, SA20090—
+3K083733Lume 2 System, Model GA0005000Lumenis, Ltd.200939—
+3K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+3K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+3K081408Ellipse MultiflexEllipse A/S20087—
+3K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+3K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008266—
+3K072034Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa2007263—
+3K072106150W Ceralas D 980NM Diode LaserBiolitec, Inc.2007229—
+3K071295100W Ceralas D 980NM Diode LaserBiolitec, Inc.2007230—
+3K063396Velure Family of Diode Lasers and Delivery Device AccessoriesLasering S.R.L.200722—
+4K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+4K250852CoolfaseAsterasys Co., Ltd.20250—
+4K251327XERFLutronic Corporation202501
+4K251632Optimas MAX SystemInMode, Ltd.20251—
+4K240857Youmagic FLM System (YM5-U1)We Medical Technology (Wuxi) Co., Ltd.20250—
+4K250189AdvaTxAdvalight Aps20250—
+4K242241SunnyShenB Co., Ltd.20250—
+4K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+4K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+4K243488Vmat ProTermosalud20250—
+4K240311JETT Medical IICompex, Spol, S.R.O.20250—