510(k) Report

Devices descending from K961748

1,230 later devices reach Medlite/Erbium Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K974641Futurelase 3000/3002 Erbium Laser SystemBuckman Co., Inc.1998241—
+1K980361Dermablate ER: Yag Laser SystemAesculap-Meditec North America1998178—
+1K974460Lite Touch Erbium Laser Treatment SystemLorad Corp.19980—
+1K972915Erbium 2000 Laser FamilyPhantom Technologies, Inc.19970—
+1K973576Epulse Model 2940 ER:Aser ER:Yag Laser SystemEpulse Technologies, Inc.19970—
+1K972347Modified Coherent Versapulse Aesthetic Surgical LaserLumenis, Inc.19971,142—
+1K971648Sharplan Erbium: Yag Laser (4020)Sharplan Lasers, Inc.199758—
+1K971459DermalaseEndo Technic Corp.19976—
+1K964253Derma 20 Laser SystemEsc Medical Systems, Ltd.19971—
+1K964128MCL 29 Dermablate Erbium Laser SystemAesculap-Meditec GmbH199767—
+2K063571Palomar LUX2940 HandpiecePalomar Medical Technologies, Inc.2007160—
+2K052354Oculase MDBiolase Technology, Inc.20065—
+2K052806BuraneWavelight Laser Technologie AG200552—
+2K050317Burane XLWavelight Laser Technologie AG200553—
+2K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd.2004517—
+2K021508Opusduo EC Dental Laser SystemOpusdent, Ltd.2002240—
+2K014057Dermastar ER:Yag Laser SystemAsclepion-Meditec AG200218—
+2K001589Candela Dynamic Cooling DeviceCandela Corp.20001,064—
+2K993671Candela Sclero Long Pulse Dye LaserCandela Corp.2000700—
+2K981438Dornier Medilas EDornier Surgical Products, Inc.199856—
+2K980313Schwartz Electro-Optics, Inc. CLR 2940 Erbium CrystalaseSchwartz Electro-Optics, Inc.19980—
+2K972872Derma K Laser SystemEsc Medical Systems, Ltd.19970—
+3K153564Pure CryogenAir Liquide Healthcare America Corporation20160—
+3K141975Waterlase Iplus SBiolase, Inc.20150—
+3K101506LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc.2010156—
+3K091320Spectra SP II, Spectra Denta IILutronic Corporation200912—
+3K082947Lensx 550 Laser SystemLensx Lasers, Inc.200951—
+3K083253Lotus II Pulsed ER: Yag Laser SystemLaseroptek Co., Ltd.20091—
+3K083900Erbium Fractional HandpiecePalomar Medical Products, Inc.2009158—
+3K073572Matrix RF ApplicatorSyneron Medical, Ltd.2008102—
+3K082028Laserpeel Soft-Met Modified Erbium LaserGlobal USA Distribution, LLC20080—
+3K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+3K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008266—
+3K072344Apl Medical SystemBios S.R.L.20076—
+3K070296Visiolite Ophthalmic ER: Yag Laser SystemAce Vision Group20070—
+3K071469Inolase Serenity PSF ( Pneumatic Skin Flattening) SystemCandela Corp.20071—
+3K063427Lumina Intense Pulsed Light (& Laser) SystemLynton Lasers Limited20070—
+3K071152Palomar Erbium HandpiecePalomar Medical Products, Inc.2007159—
+3K063867Cutera ER:Ysgg Laser HandpieceCutera, Inc.20072—
+3K060033Profile Multi-Platform SystemSciton, Inc2006221—
+3K051359Candela Family of Pulsed Dye Laser Systems: Pigmented Lesion Handpiece AccessoryCandela Corp.200511
+3K040270Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus SpectrumLumenis, Ltd.2004226—
+3K032599Medical Laser Technologies, LLC MTL Erbium:Yag Laser SystemMedical Laser Technologies, LLC200313—
+3K030181International Biophysics Corporation (Ibc) Laser Peel SystemInternational Biophysics Corp.20030—
+3K020839Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DLLumenis, Inc.20021,046—
+3K021946Cell Robotics Ultra-Light Peel Laser SystemCell Robotics, Inc.20020—
+3K014253Dermachiller 4Paradigm Trex, LLC200250—
+3K013748Candela Sclero Long Pulse Laser (Aka Vbeam)Candela Corp.2002699—
+3K993146Dornier Scanner HandpieceDornier Surgical Products, Inc.19990—
+3K984349Dornier Medilas RDornier19990—
+4K233024Alma HarmonyAlma Lasers, Inc.20241—
+4K230308Alma HarmonyAlma Lasers, Inc.20232—
+4K220214Painless IPL System - KDT750Shanghai Omni Laser Skinology Co., Ltd.20230—
+4K213761Joule diVa SystemSciton, Inc20220—
+4K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+4K192856MT OneM&T S.R.L.20202—
+4K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+4K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+4K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+4K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+4K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+4K153229SuperbiumBios S.R.L.20162—
+4K151337StrialiteCentre Light Solutions, LLC20160—
+4K141237Harmony LiteAlma, Inc.20154—
+4K132661LightscalpelLightscalpel, LLC20143—
+4K122368Waterlase Iplus All Tissue LaserBiolase Technology, Inc.20130—
+4K122200A3F FrationalPollogen, Ltd.20130—
+4K123494SOLEAConvergent Dental, Inc.201331
+4K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD.20121—
+4K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc.20123—
+4K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+4K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+4K110427Femtec Laser System for CapsulotomyTechnolas Perfect Vision GmbH20118—
+4K112098TBDLensar, Inc.20117—
+4K111350Medicam Evolux, Evostar, Evolight and Evolase Pulsed Light SystemMedicam, Inc.20110—
+4K110897Cortex CO2 / ER:Yag Laser SystemSandstone Medical Technologies, LLC20112—
+4K110907Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc.201157—
+4K102461FractoraInvasix, Ltd.201124—
+4K110502Triplex ER. Yag / ND: Yag SystemSandstone Medical Technologies, LLC20112—
+4K110304Apex ER. Yag / Ipl SystemSandstone Medical Technologies, LLC20112—
+4K101916Joule Multi-Platform SystemSciton, Inc2011111—
+4K103664Primus Aesthetic PlatformPalomar Medical Technologies, Inc.20117—
+4K102727Lensar Laser System for Anterior CapsulotomyLensar, Inc.201112—
+4K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd.201164—
+4K100610Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser SystemsLutronic Corporation20113—
+4K101321Ematrix CO2Syneron Medical, Ltd.20102—
+4K101626Lensx Laser SystemLensx Lasers, Inc.201030—
+4K090633Lensar Laser SystemLensar, Inc.201018—
+4K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+4K094052Lensx 550 Laser System. Model 550Lensx Lasers, Inc.201047—
+4K100270Artisan Aesthetic SystemPalomar Medical Technologies, Inc.2010157—
+4K090025Matrix RF ApplicatorSyneron Medical, Ltd.201018—
+4K093465Fusion SystemEclipsemed Global, Inc.20100—
+4K092647Lensx 550 Laser SystemLensx Lasers, Inc.200931—
+4K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198—
+4K082039Synchro HP PlatformEl.En Electronic Engineering Spa200919—
+4K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd.200857—
+4K082484Accelawave SystemGenesis Biosystems, Inc.200829—
+4K080530Modification to Cutera ER:Ysgg Laser HandpieceCutera, Inc.20081—
+4K082033Nannolight Intense Pulsed Light SystemGlobal USA Distribution, LLC20081591