510(k) Report

Devices descending from K961748

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K081578Accela SystemGenesis Biosystems, Inc.20080—
+4K080374Biosyag Medical SystemBios S.R.L.20082—
+4K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc.2008202—
+4K072925Candela-Inolase Serenity Pro PSF SystemInolase, Ltd.20080—
+4K071621Reliant Technologies C300 Chiller System and AccessoriesReliant Technologies, Inc.20070—
+4K070388Profile Multi-Platform SystemSciton, Inc2007129—
+4K070138Cutera ER:Yag Laser HandpieceCutera, Inc.20071—
+4K061720CosmelightPenntack Enterprises, Inc.20070—
+4K061966Litetouch Dental Laser SystemLight Instrument, Ltd.20063—
+4K060448Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd.2006297—
+4K060407Juniper Cooling DeviceJuniper Medical Technology, Inc.200636—
+4K060977Medlite C Series Compression Tool and Handpiece Attachment Accessory, Model 659-0523Hoya Conbio, Inc.20060—
+4K051508Med Flash II Intense Pulsed Light System.General Project S.R.L.20058—
+4K043329Omnilux Revive and BluePhoto Therapeutics Limited2005202—
+4K043255Ellipse Light SPTDanish Dermatologic Development A/S200525—
+4K041086Palomar Starlux Pulsed Light SystemPalomar Medical Products, Inc.2005365—
+4K043319Clareon and Solarus Pulsed Light Devices and AccessoriesNovalis Medical, LLC200415—
+4K041829Focus Medical Naturalase LP and Naturalight Family of ProductsFocus Medical, LLC20044—
+4K040659Mccue PLC Energist Ultra Variable Pulsed Light SystemMccue Plc200411—
+4K040727CRYO 5Zimmer Elektromedizin GmbH200448—
+4K032460Profile BBL SystemSciton, Inc2003569—
+4K031489PitangaSyneron Medical, Ltd.20030—
+4K030342Lumenis Family of Ipl Systems and Combination Ipl/ND:Yag SystemsLumenis, Ltd.20037561
+4K030426Omnilux RedPhoto Therapeutics Limited2003563—
+4K024259Pulsed Light Therapy System, Model# UV-300New Star Lasers, Inc.20030—
+4K024093Modified Lumenis Family of Intense Pulsed-Light (Ipl) and Combination Ipl Systems and…Lumenis, Ltd.2003756—
+4K030527Lumenis Family of Ipl and Combination Ipl/ND:Yag SystemsLumenis2003856—
+4K022226Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future…Altus Medical, Inc.2002665—
+4K021180Candela Vbeam Pulsed Dye Laser SystemCandela Corp.2002318—
+5K252561BTL-754FFBTL Industries, Inc.20260—
+5K251545Intense Pulsed Light Therapy Device (MMABM-1)Micowey Medical Equipment (Guangxi) Co., Ltd.20250—
+5K244060eCO2 3DLutronic Corporation20250—
+5K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+5K231948MediyagMedicreations, LLC20240—
+5K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+5K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+5K233473Deka LotusEl.En S.P.A.20241—
+5K234057NirvanaEl.En S.P.A.20240—
+5K221766SolonLmg Lasers Comercio, Importacao E Exportacao Ltda20240—
+5K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+5K232716Q-Switched Nd:Yag laserHebei Zhemai Technology Co., Ltd.20231—
+5K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+5K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+5K22079410PLTentech Co., Ltd.20220—
+5K212790XLase PlusBiotec Italia, Srl20220—
+5K221571InMode Multi-systemInMode, Ltd.20222—
+5K210183Waterlase iPLusBiolase, Inc.20220—
+5K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+5K203728DarwinLuvo Medical Technologies, Inc.20211—
+5K203299CellFX SystemPulse Biosciences, Inc.20214—
+5K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+5K200616E>EyeCE-Swin20200—
+5K200104OxylightRaja Trading Company, Inc.202024—
+5K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+5K193656SkyPulseFotona D.O.O.202011—
+5K180359BTL-FR2000BTL Industries, Inc.20189—
+5K180508Joule SystemSciton, Inc20183—
+5K173285Joule SystemSciton, Inc20185—
+5K172413MT ONEM&T S.R.L.20175—
+5K171337LENSAR Laser System – fs 3D (LLS-fs 3D)Lensar, Inc.20170—
+5K170073LightMed Dental Laser SystemLightmed Dentaltechnology Corp.20170—
+5K163196ACTION II Laser SystemLutronic Corporation20170—
+5K162851eLyx-PROIntelligent Sensory Concept SA20170—
+5K161288LenSX Laser SystemAlcon Laboratories, Inc.20164—
+5K160075Accent XLAlma Lasers, Inc.20160—
+5K152714Quanta ForteQuanta System Spa201513—
+5K151306SoleaConvergent Dental, Inc.20151—
+5K151655CO2RE SystemSyneron Medical, Ltd.20151—
+5K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+5K150161Venus Viva SR DeviceVenus Concept, Ltd.20159—
+5K150336Photonica ProfessionalWard Photonics, LLC20157—
+5K142860Lumenis M22 SystemLumenis, Ltd.2015381
+5K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+5K141658Light ScalpelLightscalpel, LLC20142—
+5K140670Ellipse I2PL+/Ellipse Multiflex+Ellipse A/S201461
+5K142376Palomar Icon Aesthetic SystemCynosure, Inc.201413—
+5K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+5K140615Victus Femtosecond Laser PlatformTechnolas Perfect Vision GmbH20143—
+5K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+5K131712A-Tone Ipl SystemYbk Investment, Inc.20140—
+5K134017GigalaserPowermedic Aps20141—
+5K132976AdvatxAdvalight Aps20141—
+5K133837Viora V-TotalViora, Ltd.201433—
+5K133319ET Lightsheer 1060, High Speed Lightsheer 1060Lumenis, Ltd.201424—
+5K130501IntensifEndymed Medical, Ltd.201457—
+5K131758Surgen UPollogen, Ltd.20135—
+5K130028Resurfx 1565NM Laser ModuleLumenis, Ltd.201341—
+5K130420SOLEAConvergent Dental, Inc.201321
+5K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+5K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—
+5K123777Multilaser SystemUltralight Laser Technologies, LLC20131—
+5K123860Inmode SR Ipl DeviceInmode MD, Ltd.20133—
+5K123859TBDLensar, Inc.20134—
+5K122386Victus Femtosecond Laser PlatformTechnolas Perfect Vision GmbH20136—
+5K122829Lensar Laser System - FS 3D for Corneal IncisionsLensar, Inc.20125—
+5K120460SmartluxMedmix Co., Ltd.201218—
+5K120732Lenssx Laser SystemAlcon Lensx, Inc.2012121
+5K120426Victus Laser PlatformTechnolas Perfect Vision GmbH20127—
+5K120214TBDLensar, Inc.20126—
+5K120622Palomar Vectus LaserPalomar Medical Technologies, Inc.20124—