510(k) Report

Devices descending from K013028

906 later devices reach Palomar SLP 1000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K220103LED Therapy Device (Planar LED/Planar LED mini)Shenzhen Leaflife Technology Co., Ltd.20221—
+4K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+4K203728DarwinLuvo Medical Technologies, Inc.20211—
+4K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+4K192621Medical RFTriworks Group Srl20200—
+4K200616E>EyeCE-Swin20200—
+4K200525Medical Diode Laser Hair Removal SystemWeifang Mingliang Electronics Co., Ltd.20201—
+4K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+4K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+4K193656SkyPulseFotona D.O.O.202011—
+4K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+4K192569Diode Laser Therapy SystemSan HE Lefis Electronics Co., Ltd.20191—
+4K192516Diode Laser 808nmBeijing Superlaser Technology Co., Ltd.20191—
+4K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+4K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+4K180508Joule SystemSciton, Inc20183—
+4K173285Joule SystemSciton, Inc20185—
+4K172791Lumilisse IPL Hair RemoverConair Corporation201825—
+4K172413MT ONEM&T S.R.L.20175—
+4K162659Diode Laser Hair Removal SystemShandong Huamei Technology Co., Ltd.201740—
+4K163196ACTION II Laser SystemLutronic Corporation20170—
+4K163173Handheld Diode Laser for Hair RemovalLiaoning Sidey Optoelectronics Technologies Co., Ltd.20170—
+4K161692Diode Laser Therapy MachineBeijing Adss Development Co., Ltd.20166—
+4K161981Olive PlusAma Network, Inc.20160—
+4K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+4K152898Diode Laser Therapy SystemsBeijing Sincoheren Science and Tech. Development Co., Ltd.20161—
+4K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+4K152714Quanta ForteQuanta System Spa201513—
+4K143003iPulse Smooth Skin Gold Hair Removal SystemIpulse Limited2015123—
+4K142186Diode Laser Hair Removal SystemShenzhen Gsd Tech Co., Ltd.20151—
+4K141986Elux 810 LaserEquipmed North America, Inc.20150—
+4K143339Mini meIluminage Ltd.(Formerly Syneron Beauty Ltd.)20140—
+4K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+4K140926Inmode Wmface DeviceInmode MD, Ltd.20143—
+4K141973Diode Laser Hair Removal SystemBeijing Anchorfree Technology Co., Ltd.201448—
+4K132518Nubrilliance Pulsed Light Hair Removal DeviceWellquest Intl., Inc.20140—
+4K140381Sensilight/ Sensilight PlusEl Global Trade, Ltd.201414—
+4K140527Sensilight MiniEl Global Trade, Ltd.201423—
+4K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+4K133405MinnieElettronica Valseriana Srl20140—
+4K132976AdvatxAdvalight Aps20141—
+4K133837Viora V-TotalViora, Ltd.201433—
+4K130501IntensifEndymed Medical, Ltd.201457—
+4K132431Thermage CPT SystemSolta Medical, Inc.2013171
+4K130793Newa Skin Therapy SystemEndymion Medical, Ltd.20130—
+4K131870Glide DeviceHome Skinovations, Ltd.201333—
+4K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+4K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—
+4K123845MESyneron Beauty, Ltd.2013126—
+4K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc.20123—
+4K120080Shaser HRS2 Hair Removal SystemShaser, Inc.2012135—
+4K112669Tattoostar Effect YAsclepion Laser Technologies GmbH20128—
+4K120513Glow by EndymedEndymed Medical, Ltd.20125—
+4K111670Venus Freeze (MP)2 SystemVenus Concept, Ltd.201213—
+4K111026ApolloPollogen, Ltd.201114—
+4K111784Venus Swan SystemVenus Concept, Ltd.20111—
+4K110672Etwo Skin Treatment SystemSyneron, Ltd.20112—
+4K102954Cutera Qswitch Laser SystemCutera, Inc.201149—
+4K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd.201164—
+4K103288Deka Synchro FTEl.En Electronic Engineering Spa201118—
+4K101147Modified Alma Lasers Family of Accent Radiofrequency (RF) SystemAlma Lasers, Inc.20114—
+4K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc.2010921
+4K101321Ematrix CO2Syneron Medical, Ltd.20102—
+4K101573Accusculpt II Laser SystemLutronic Corporation20101—
+4K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+4K101967Non-Ablative Wrinkle Treatent Handpiece Modle Pelleve'Ellman Int'L, Inc.201053—
+4K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+4K090025Matrix RF ApplicatorSyneron Medical, Ltd.201018—
+4K092191Exilis, Model 5000Btl Industries, Ltd.200912—
+4K091323Modified Intermedic Diode Laser 980NM System (Multidiode SST 200)Intermedic Arfran, SA20090—
+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—
+4K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+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—
+4K072699Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models: Accent, Accent XLAlma Lasers, Ltd.200784—
+4K072034Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa2007263—
+4K072106150W Ceralas D 980NM Diode LaserBiolitec, Inc.2007229—
+4K071295100W Ceralas D 980NM Diode LaserBiolitec, Inc.2007230—
+4K063396Velure Family of Diode Lasers and Delivery Device AccessoriesLasering S.R.L.200722—
+4K060448Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd.2006297—
+5K261975Braun Aura 7 (6041)CyDen Limited20260—
+5K261977Braun Aura 9 (6042)Cyden Limited20260—
+5K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+5K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+5K260153Q-Switched Nd: YAG Laser System (Glamor Q)Nanjing Bestview Laser S&T Co., Ltd.20260—
+5K254047Hair Removal Device (CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12 Pro, CTU05, CTU07…Shenzhen Chuangtong Yigou Technology Co., Ltd.20260—
+5K253666IPL Hair Removal Device (Models: T31A, T32A)Shenzhen Mlay Intelligent Technology Co., Ltd.20260—
+5K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+5K252618IPL Hair Removal Device (I6 S1, I6 D1, I6 M1)Alovea Healthcare Co., Ltd.20250—
+5K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+5K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+5K242859VEGAIbramed Equipamentos Médicos20250—
+5K251339Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03…Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+5K250165PastelleWontech Co., Ltd.20250—
+5K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+5K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)Beijing Sano Laser S&T Development Co.,Ltd20250—