510(k) Report

Devices descending from K040005

572 later devices reach Profile 2000/3000 Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082947Lensx 550 Laser SystemLensx Lasers, Inc.200951—
+1K063571Palomar LUX2940 HandpiecePalomar Medical Technologies, Inc.2007160—
+1K060033Profile Multi-Platform SystemSciton, Inc2006221—
+1K052806BuraneWavelight Laser Technologie AG200552—
+1K050317Burane XLWavelight Laser Technologie AG200553—
+1K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd.2004517—
+2K213761Joule diVa SystemSciton, Inc20220—
+2K141975Waterlase Iplus SBiolase, Inc.20150—
+2K122368Waterlase Iplus All Tissue LaserBiolase Technology, Inc.20130—
+2K110427Femtec Laser System for CapsulotomyTechnolas Perfect Vision GmbH20118—
+2K112098TBDLensar, Inc.20117—
+2K101916Joule Multi-Platform SystemSciton, Inc2011111—
+2K102727Lensar Laser System for Anterior CapsulotomyLensar, Inc.201112—
+2K101626Lensx Laser SystemLensx Lasers, Inc.201030—
+2K101506LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc.2010156—
+2K090633Lensar Laser SystemLensar, Inc.201018—
+2K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+2K094052Lensx 550 Laser System. Model 550Lensx Lasers, Inc.201047—
+2K092647Lensx 550 Laser SystemLensx Lasers, Inc.200931—
+2K083900Erbium Fractional HandpiecePalomar Medical Products, Inc.2009158—
+2K073572Matrix RF ApplicatorSyneron Medical, Ltd.2008102—
+2K082028Laserpeel Soft-Met Modified Erbium LaserGlobal USA Distribution, LLC20080—
+2K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+2K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008266—
+2K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc.2008202—
+2K072344Apl Medical SystemBios S.R.L.20076—
+2K063427Lumina Intense Pulsed Light (& Laser) SystemLynton Lasers Limited20070—
+2K071152Palomar Erbium HandpiecePalomar Medical Products, Inc.2007159—
+2K070388Profile Multi-Platform SystemSciton, Inc2007129—
+2K070138Cutera ER:Yag Laser HandpieceCutera, Inc.20071—
+2K063867Cutera ER:Ysgg Laser HandpieceCutera, Inc.20072—
+2K052354Oculase MDBiolase Technology, Inc.20065—
+2K051359Candela Family of Pulsed Dye Laser Systems: Pigmented Lesion Handpiece AccessoryCandela Corp.200511
+3K233024Alma HarmonyAlma Lasers, Inc.20241—
+3K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+3K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+3K230308Alma HarmonyAlma Lasers, Inc.20232—
+3K220214Painless IPL System - KDT750Shanghai Omni Laser Skinology Co., Ltd.20230—
+3K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+3K192856MT OneM&T S.R.L.20202—
+3K193656SkyPulseFotona D.O.O.202011—
+3K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+3K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+3K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+3K173285Joule SystemSciton, Inc20185—
+3K171337LENSAR Laser System – fs 3D (LLS-fs 3D)Lensar, Inc.20170—
+3K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+3K161288LenSX Laser SystemAlcon Laboratories, Inc.20164—
+3K153229SuperbiumBios S.R.L.20162—
+3K141237Harmony LiteAlma, Inc.20154—
+3K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+3K140615Victus Femtosecond Laser PlatformTechnolas Perfect Vision GmbH20143—
+3K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+3K132976AdvatxAdvalight Aps20141—
+3K122200A3F FrationalPollogen, Ltd.20130—
+3K123859TBDLensar, Inc.20134—
+3K122386Victus Femtosecond Laser PlatformTechnolas Perfect Vision GmbH20136—
+3K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD.20121—
+3K122829Lensar Laser System - FS 3D for Corneal IncisionsLensar, Inc.20125—
+3K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc.20123—
+3K120732Lenssx Laser SystemAlcon Lensx, Inc.2012121
+3K120426Victus Laser PlatformTechnolas Perfect Vision GmbH20127—
+3K120214TBDLensar, Inc.20126—
+3K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+3K113151Ifs Laser SystemAbbott Medical Optics, Inc.201219—
+3K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+3K113479Optimedica Catalys Precision Laser SystemOptimedica Corporation2011132
+3K110364Dornier Medilas D Litebeam+ 1470Dornier Medtech America, Inc.20117—
+3K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+3K110907Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc.201157—
+3K102461FractoraInvasix, Ltd.201124—
+3K103664Primus Aesthetic PlatformPalomar Medical Technologies, Inc.20117—
+3K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd.201164—
+3K101321Ematrix CO2Syneron Medical, Ltd.20102—
+3K101573Accusculpt II Laser SystemLutronic Corporation20101—
+3K100270Artisan Aesthetic SystemPalomar Medical Technologies, Inc.2010157—
+3K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+3K090025Matrix RF ApplicatorSyneron Medical, Ltd.201018—
+3K093465Fusion SystemEclipsemed Global, Inc.20100—
+3K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+3K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198—
+3K082039Synchro HP PlatformEl.En Electronic Engineering Spa200919—
+3K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+3K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+3K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd.200857—
+3K081352Profile Multi-Platform SystemSciton, Inc2008112—
+3K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+3K080530Modification to Cutera ER:Ysgg Laser HandpieceCutera, Inc.20081—
+3K080374Biosyag Medical SystemBios S.R.L.20082—
+3K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+3K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+3K070296Visiolite Ophthalmic ER: Yag Laser SystemAce Vision Group20070—
+3K060977Medlite C Series Compression Tool and Handpiece Attachment Accessory, Model 659-0523Hoya Conbio, Inc.20060—
+4K252561BTL-754FFBTL Industries, Inc.20260—
+4K252658Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd.20251—
+4K250261Heager Medical Laser Family (Sabrina/Adolf)Heager GmbH20250—
+4K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+4K250189AdvaTxAdvalight Aps20250—
+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—