510(k) Report

Devices descending from K954013

1,233 later devices reach Trilase 2940 Erbium Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K122386Victus Femtosecond Laser PlatformTechnolas Perfect Vision GmbH20136—
+5K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD.20121—
+5K122829Lensar Laser System - FS 3D for Corneal IncisionsLensar, Inc.20125—
+5K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc.20123—
+5K120732Lenssx Laser SystemAlcon Lensx, Inc.2012121
+5K120426Victus Laser PlatformTechnolas Perfect Vision GmbH20127—
+5K120214TBDLensar, Inc.20126—
+5K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+5K113151Ifs Laser SystemAbbott Medical Optics, Inc.201219—
+5K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+5K113479Optimedica Catalys Precision Laser SystemOptimedica Corporation2011132
+5K111831MX-7000 MicroxelBio-Med USA, Inc.20111—
+5K111350Medicam Evolux, Evostar, Evolight and Evolase Pulsed Light SystemMedicam, Inc.20110—
+5K110907Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc.201157—
+5K102461FractoraInvasix, Ltd.201124—
+5K101916Joule Multi-Platform SystemSciton, Inc2011111—
+5K103664Primus Aesthetic PlatformPalomar Medical Technologies, Inc.20117—
+5K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd.201164—
+5K101321Ematrix CO2Syneron Medical, Ltd.20102—
+5K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+5K100270Artisan Aesthetic SystemPalomar Medical Technologies, Inc.2010157—
+5K090025Matrix RF ApplicatorSyneron Medical, Ltd.201018—
+5K093465Fusion SystemEclipsemed Global, Inc.20100—
+5K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198—
+5K082039Synchro HP PlatformEl.En Electronic Engineering Spa200919—
+5K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd.200857—
+5K082484Accelawave SystemGenesis Biosystems, Inc.200829—
+5K082033Nannolight Intense Pulsed Light SystemGlobal USA Distribution, LLC20081591
+5K081578Accela SystemGenesis Biosystems, Inc.20080—
+5K080374Biosyag Medical SystemBios S.R.L.20082—
+5K073411LiteduoLight Instruments20081—
+5K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc.2008202—
+5K072925Candela-Inolase Serenity Pro PSF SystemInolase, Ltd.20080—
+5K071621Reliant Technologies C300 Chiller System and AccessoriesReliant Technologies, Inc.20070—
+5K070388Profile Multi-Platform SystemSciton, Inc2007129—
+5K061720CosmelightPenntack Enterprises, Inc.20070—
+5K060448Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd.2006297—
+5K060407Juniper Cooling DeviceJuniper Medical Technology, Inc.200636—
+5K060977Medlite C Series Compression Tool and Handpiece Attachment Accessory, Model 659-0523Hoya Conbio, Inc.20060—
+5K051508Med Flash II Intense Pulsed Light System.General Project S.R.L.20058—
+5K043329Omnilux Revive and BluePhoto Therapeutics Limited2005202—
+5K043255Ellipse Light SPTDanish Dermatologic Development A/S200525—
+5K041086Palomar Starlux Pulsed Light SystemPalomar Medical Products, Inc.2005365—
+5K043319Clareon and Solarus Pulsed Light Devices and AccessoriesNovalis Medical, LLC200415—
+5K041829Focus Medical Naturalase LP and Naturalight Family of ProductsFocus Medical, LLC20044—
+5K040659Mccue PLC Energist Ultra Variable Pulsed Light SystemMccue Plc200411—
+5K040727CRYO 5Zimmer Elektromedizin GmbH200448—
+5K032460Profile BBL SystemSciton, Inc2003569—
+5K031489PitangaSyneron Medical, Ltd.20030—
+5K030342Lumenis Family of Ipl Systems and Combination Ipl/ND:Yag SystemsLumenis, Ltd.20037561
+5K030426Omnilux RedPhoto Therapeutics Limited2003563—
+5K024259Pulsed Light Therapy System, Model# UV-300New Star Lasers, Inc.20030—
+5K024093Modified Lumenis Family of Intense Pulsed-Light (Ipl) and Combination Ipl Systems and…Lumenis, Ltd.2003756—
+5K030527Lumenis Family of Ipl and Combination Ipl/ND:Yag SystemsLumenis2003856—
+5K022226Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future…Altus Medical, Inc.2002665—
+5K021180Candela Vbeam Pulsed Dye Laser SystemCandela Corp.2002318—
+6K252561BTL-754FFBTL Industries, Inc.20260—
+6K251545Intense Pulsed Light Therapy Device (MMABM-1)Micowey Medical Equipment (Guangxi) Co., Ltd.20250—
+6K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+6K231948MediyagMedicreations, LLC20240—
+6K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+6K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+6K233473Deka LotusEl.En S.P.A.20241—
+6K234057NirvanaEl.En S.P.A.20240—
+6K221766SolonLmg Lasers Comercio, Importacao E Exportacao Ltda20240—
+6K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+6K232716Q-Switched Nd:Yag laserHebei Zhemai Technology Co., Ltd.20231—
+6K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+6K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+6K213669Lightscalpel LS-4020Lightscalpel, Inc.20230—
+6K22079410PLTentech Co., Ltd.20220—
+6K221761SoleaConvergent Dental, Inc.202201
+6K212790XLase PlusBiotec Italia, Srl20220—
+6K221571InMode Multi-systemInMode, Ltd.20222—
+6K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+6K203728DarwinLuvo Medical Technologies, Inc.20211—
+6K203299CellFX SystemPulse Biosciences, Inc.20214—
+6K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+6K200616E>EyeCE-Swin20200—
+6K200104OxylightRaja Trading Company, Inc.202024—
+6K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+6K193656SkyPulseFotona D.O.O.202011—
+6K180359BTL-FR2000BTL Industries, Inc.20189—
+6K173827LightScalpelLightscalpel, LLC20180—
+6K173359Fractional CO2 Surgical Laser SystemAmi, Inc.20180—
+6K180508Joule SystemSciton, Inc20183—
+6K173285Joule SystemSciton, Inc20185—
+6K172413MT ONEM&T S.R.L.20175—
+6K163196ACTION II Laser SystemLutronic Corporation20170—
+6K163551LenSx Laser SystemAlcon Laboratories, Inc.20173—
+6K162851eLyx-PROIntelligent Sensory Concept SA20170—
+6K160075Accent XLAlma Lasers, Inc.20160—
+6K152714Quanta ForteQuanta System Spa201513—
+6K151655CO2RE SystemSyneron Medical, Ltd.20151—
+6K151161VICTUS Femtosecond Laser PlatformTechnolas Perfect Vision GmbH20152—
+6K150161Venus Viva SR DeviceVenus Concept, Ltd.20159—
+6K143010LENSAR Laser System - fs 3DLensar, Inc.20153—
+6K150336Photonica ProfessionalWard Photonics, LLC20157—
+6K142860Lumenis M22 SystemLumenis, Ltd.2015381
+6K141852Ifs Advanced Femtosecond Laser SystemAmo Manufacturing USA, LLC20155—