510(k) Report

Devices descending from K041879

416 later devices reach Palomar LUX1064 Handpiece through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110907Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc.201157—
+1K103664Primus Aesthetic PlatformPalomar Medical Technologies, Inc.20117—
+1K081408Ellipse MultiflexEllipse A/S20087—
+1K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008266—
+1K060033Profile Multi-Platform SystemSciton, Inc2006221—
+2K233473Deka LotusEl.En S.P.A.20241—
+2K233024Alma HarmonyAlma Lasers, Inc.20241—
+2K230308Alma HarmonyAlma Lasers, Inc.20232—
+2K220214Painless IPL System - KDT750Shanghai Omni Laser Skinology Co., Ltd.20230—
+2K213761Joule diVa SystemSciton, Inc20220—
+2K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+2K192856MT OneM&T S.R.L.20202—
+2K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+2K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+2K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+2K173285Joule SystemSciton, Inc20185—
+2K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+2K153229SuperbiumBios S.R.L.20162—
+2K141237Harmony LiteAlma, Inc.20154—
+2K141975Waterlase Iplus SBiolase, Inc.20150—
+2K140670Ellipse I2PL+/Ellipse Multiflex+Ellipse A/S201461
+2K142376Palomar Icon Aesthetic SystemCynosure, Inc.201413—
+2K130028Resurfx 1565NM Laser ModuleLumenis, Ltd.201341—
+2K122368Waterlase Iplus All Tissue LaserBiolase Technology, Inc.20130—
+2K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD.20121—
+2K120622Palomar Vectus LaserPalomar Medical Technologies, Inc.20124—
+2K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+2K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+2K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+2K101916Joule Multi-Platform SystemSciton, Inc2011111—
+2K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+2K093465Fusion SystemEclipsemed Global, Inc.20100—
+2K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198—
+2K082039Synchro HP PlatformEl.En Electronic Engineering Spa200919—
+2K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd.200857—
+2K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+2K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc.2008202—
+2K070388Profile Multi-Platform SystemSciton, Inc2007129—
+2K070138Cutera ER:Yag Laser HandpieceCutera, Inc.20071—
+2K063867Cutera ER:Ysgg Laser HandpieceCutera, Inc.20072—
+3K252561BTL-754FFBTL Industries, Inc.20260—
+3K250281Deka LotusEl.En S.P.A.20250—
+3K241270BTL-754BTL Industries, Inc.20251—
+3K231948MediyagMedicreations, LLC20240—
+3K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+3K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+3K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+3K234057NirvanaEl.En S.P.A.20240—
+3K221766SolonLmg Lasers Comercio, Importacao E Exportacao Ltda20240—
+3K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+3K232716Q-Switched Nd:Yag laserHebei Zhemai Technology Co., Ltd.20231—
+3K230077LaserMENeauvia North America20232—
+3K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+3K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+3K22079410PLTentech Co., Ltd.20220—
+3K212790XLase PlusBiotec Italia, Srl20220—
+3K203728DarwinLuvo Medical Technologies, Inc.20211—
+3K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+3K200616E>EyeCE-Swin20200—
+3K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+3K193656SkyPulseFotona D.O.O.202011—
+3K193426Elite iQCynosure, LLC20201—
+3K180508Joule SystemSciton, Inc20183—
+3K172413MT ONEM&T S.R.L.20175—
+3K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+3K163196ACTION II Laser SystemLutronic Corporation20170—
+3K162765Venus Velocity Diode Laser SystemVenus Concept, Ltd.20171—
+3K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+3K152714Quanta ForteQuanta System Spa201513—
+3K150907Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner…Ellipse A/S20155—
+3K142860Lumenis M22 SystemLumenis, Ltd.2015381
+3K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+3K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+3K132976AdvatxAdvalight Aps20141—
+3K133837Viora V-TotalViora, Ltd.201433—
+3K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+3K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—
+3K110364Dornier Medilas D Litebeam+ 1470Dornier Medtech America, Inc.20117—
+3K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+3K102954Cutera Qswitch Laser SystemCutera, Inc.201149—
+3K103288Deka Synchro FTEl.En Electronic Engineering Spa201118—
+3K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc.2010921
+3K101321Ematrix CO2Syneron Medical, Ltd.20102—
+3K101573Accusculpt II Laser SystemLutronic Corporation20101—
+3K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+3K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+3K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+3K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+3K081352Profile Multi-Platform SystemSciton, Inc2008112—
+3K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+3K080530Modification to Cutera ER:Ysgg Laser HandpieceCutera, Inc.20081—
+3K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+3K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+4K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+4K260153Q-Switched Nd: YAG Laser System (Glamor Q)Nanjing Bestview Laser S&T Co., Ltd.20260—
+4K252658Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd.20251—
+4K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+4K250261Heager Medical Laser Family (Sabrina/Adolf)Heager GmbH20250—
+4K250165PastelleWontech Co., Ltd.20250—
+4K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)Beijing Sano Laser S&T Development Co.,Ltd20250—