510(k) Report

Devices descending from K051214

476 later devices reach Aluma Skin Renewal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192621Medical RFTriworks Group Srl20200—
+1K112669Tattoostar Effect YAsclepion Laser Technologies GmbH20128—
+1K100586Venus Freeze SystemVenus Concept, Ltd.201031—
+1K083461Imagine TC Skin Therapy SystemEndymion Medical, Ltd.2009101—
+1K083590Iskra Medical Green Irf PrestigeIskra Medical, D.O.O.200913—
+1K070004AccentAlma Lasers, Ltd.2007181—
+1K060448Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd.2006297—
+2K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+2K173692D-Actor 200 Vibration Massage SystemStorz Medical AG20186—
+2K142860Lumenis M22 SystemLumenis, Ltd.2015381
+2K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+2K140926Inmode Wmface DeviceInmode MD, Ltd.20143—
+2K131757Tattoostar Effect ComboAsclepion Laser Technologies GmbH20140—
+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—
+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—
+2K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd.201164—
+2K101147Modified Alma Lasers Family of Accent Radiofrequency (RF) SystemAlma Lasers, Inc.20114—
+2K101967Non-Ablative Wrinkle Treatent Handpiece Modle Pelleve'Ellman Int'L, Inc.201053—
+2K090025Matrix RF ApplicatorSyneron Medical, Ltd.201018—
+2K093465Fusion SystemEclipsemed Global, Inc.20100—
+2K092191Exilis, Model 5000Btl Industries, Ltd.200912—
+2K083733Lume 2 System, Model GA0005000Lumenis, Ltd.200939—
+2K082622Alma Lasers Accent B-Shape Massager Handpiece/ModuleAlma Lasers, Ltd.200945—
+2K081408Ellipse MultiflexEllipse A/S20087—
+2K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008266—
+2K072699Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models: Accent, Accent XLAlma Lasers, Ltd.200784—
+3K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+3K243488Vmat ProTermosalud20250—
+3K233024Alma HarmonyAlma Lasers, Inc.20241—
+3K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+3K222556BTL-785XBTL Industries, Inc.20235—
+3K221865BTL-094BTL Industries, Inc.20230—
+3K230308Alma HarmonyAlma Lasers, Inc.20232—
+3K220214Painless IPL System - KDT750Shanghai Omni Laser Skinology Co., Ltd.20230—
+3K210166Omnispec ED1000Medispec, Ltd.20230—
+3K220538DolorClast RadialE.M.S Electro Medical Systems S.A20221—
+3K221571InMode Multi-systemInMode, Ltd.20222—
+3K211639BTL-785WBTL Industries, Inc.20227—
+3K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+3K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+3K210451OrthoGold 100Tissue Regeneration Technologies, LLC20212—
+3K193201BTL-785FBtl20208—
+3K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+3K192856MT OneM&T S.R.L.20202—
+3K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+3K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+3K180359BTL-FR2000BTL Industries, Inc.20189—
+3K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+3K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+3K173759Thermage CPT System and AccessoriesSolta Medical201821
+3K170758Thermage FLX System and AccessoriesSolta Medical201713—
+3K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+3K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+3K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+3K160312Fraxis DuoIlooda Co,., Ltd.201614—
+3K160075Accent XLAlma Lasers, Inc.20160—
+3K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+3K153229SuperbiumBios S.R.L.20162—
+3K153566Magma SystemFormatk Systems, Ltd.20162—
+3K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+3K141237Harmony LiteAlma, Inc.20154—
+3K142910Legacy BXVenus Concept USA, Inc.201411—
+3K140670Ellipse I2PL+/Ellipse Multiflex+Ellipse A/S201461
+3K140629Venus Swan (MP)2Venus Concept, Ltd.20140—
+3K140255Stop U (Packed Black Usa); Stop U (Packed White Usa)Pollogen, Ltd.20147—
+3K120510TranscendSyneron Medical, Ltd.201318—
+3K122966XP200Btl Industries, Ltd.20131—
+3K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD.20121—
+3K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+3K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+3K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+3K101916Joule Multi-Platform SystemSciton, Inc2011111—
+3K102698Pelleve Glidesafe Non-Ablative Wrinkle Treatment System Model Pelleve GlidesafeEllman Int'L, Inc.201139—
+3K102368Non-Ablative Wrinkle Treatment HandpieceEllman Int'L, Inc.201052—
+3K092195Cutera Multimodal Cellulite Product (Cmmcd)Cutera, Inc.20090—
+3K090580Thermage Thermacool NXT System and AccessoriesSolta Medical, Inc.200919—
+3K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198—
+3K082039Synchro HP PlatformEl.En Electronic Engineering Spa200919—
+3K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd.200857—
+3K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+4K252561BTL-754FFBTL Industries, Inc.20260—
+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—
+4K242241SunnyShenB Co., Ltd.20250—
+4K240311JETT Medical IICompex, Spol, S.R.O.20250—
+4K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+4K242688Finiff SystemSkingrab Co., Ltd.20240—
+4K231948MediyagMedicreations, LLC20240—
+4K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—