510(k) Report

Devices descending from K914136

1,315 later devices reach Coherent Versapulse (TM) 2.1XE/2.1L Holmi Surg Lase through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K031046Thermacool TC SystemThermage, Inc.200322—
+5K024064Polaris DSSyneron Medical, Ltd.2003681—
+5K030142Thermacool TC SystemThermage, Inc.2003773—
+5K022475Modification to Arthrocare Controller (System 2000 and 8000), Arthrocare Patient Cable…Arthrocare Corp.20020—
+6K261202ENTire IRE SystemEntire Medical, Ltd.20260—
+6K252971Elyra™ Thulium Fiber Laser System and Elyra™ Plus Thulium Fiber Laser System (Laser…C.R. Bard, Inc.20260—
+6K251303Tamburo Thulium Fiber Laser SystemMenovex Medical Technology (Shenzhen) Co., Ltd.20250—
+6K251824Patriot DuoPatriot Laser, LLC20250—
+6K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+6K241643WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)Wontech Co., Ltd.20252—
+6K250068Venclose digiRF Generator (VCRFG1)Venclose, Inc.202511
+6K243147LGO-Surgical Laser FibersLight Guide Optics International, Ltd.20241—
+6K240070Profound MatrixCandela Corporation20240—
+6K232769BeaMed Laser Surgery FibersBt Beamedical Tachnoogies Ltd. (Beamed)20231—
+6K231749Radio Frequency SystemShenzhenshi Sincoheren S&T Development Co., Ltd.20230—
+6K222556BTL-785XBTL Industries, Inc.20235—
+6K230819OmniGuide RFID Surgical Laser FibersOmni-Guide Holdings, Inc.20230—
+6K222260Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500Capenergy Medical S.L.20233—
+6K222709Retraction, CWM-910T, APOLEX TiteChungwoo Co., Ltd.20230—
+6K221306SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed…Gyrus Acmi, Inc.202348
+6K220793InnoVoyce Laser FiberInnovoyce, LLC20220—
+6K211639BTL-785WBTL Industries, Inc.20227—
+6K210077MED RF 4000F Care Systems USA, LLC20211—
+6K211217Profound MatrixCandela Corporation20210—
+6K211517Optica XT Thulium Fiber Laser and Accessories, also known as Optica XT, Optica XT…Convergent Laser Technologies20210—
+6K211838Ultrasonic Bipolar Generator USG-410 with accessoriesOlympus Medical Systems Corporation2021313
+6K211401SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser…Gyrus Acmi, Inc.202171
+6K192621Medical RFTriworks Group Srl20200—
+6K193201BTL-785FBtl20208—
+6K200104OxylightRaja Trading Company, Inc.202024—
+6K192103Thunderbeat Open Fine Jaw Type X Hand InstrumentOlympus Medical Systems Corp.20204—
+6K192600Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60Quanta System Spa20205—
+6K192990Litho EvoQuanta System Spa20190—
+6K190610Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologySterilmed, Inc.20190—
+6K180359BTL-FR2000BTL Industries, Inc.20189—
+6K180945LUTRONIC GENIUS Radiofrequency SystemLutronic Corporation20181—
+6K180872Scarlet SRFVIOL Co., Ltd.20184—
+6K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+6K180922Empower H100, Cyber Ho 100, Litho 100Quanta System Spa20186—
+6K180584Viveve RF System, SecureViveve, Inc.20185—
+6K173759Thermage CPT System and AccessoriesSolta Medical201821
+6K172023CelfirmVIOL Co., Ltd.20173—
+6K170758Thermage FLX System and AccessoriesSolta Medical201713—
+6K170908PK AIMGyrus Acmi, Inc.20170—
+6K170456Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologyStryker Sustainability Solutions201701
+6K170116Thermi Injectable RF ElectrodesThermi20172—
+6K161949OsteoCool V-3 RF Ablation SystemBaylis Medical Company, Inc.20177—
+6K162851eLyx-PROIntelligent Sensory Concept SA20170—
+6K163190InMode RF SystemInmode MD, Ltd.20160—
+6K160312Fraxis DuoIlooda Co,., Ltd.201614—
+6K161825PK AIMGyrus Acmi, Inc.20162—
+6K161403A.R.C. Laser Surgical Fibers and ProbesA.R.C Laser GmbH20160—
+6K153727INTRAcel Premium Fractional RF Micro Needle (FRM) SystemJeisys Medical, Inc.201627—
+6K153371Sonicision Cordless Ultrasonic Dissection DeviceCovidien, LLC20164—
+6K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+6K150409VIVACE Electrosurgical SystemSung Hwan E&B Co.,Ltd201681
+6K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+6K150524Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue TechnologySurgical Instrument Services and Savings, Inc.20150—
+6K151629Guardian 1000Quanta System Spa20150—
+6K151340HARMONIC Focus Long Shears + Adaptive Tissue TechnologyEthicon Endo-Surgery, LLC20150—
+6K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+6K150336Photonica ProfessionalWard Photonics, LLC20157—
+6K142759PK Cutting Forceps for ESG-400 WorkstationGyrus Acmi, Inc.20152—
+6K133405MinnieElettronica Valseriana Srl20140—
+6K134017GigalaserPowermedic Aps20141—
+6K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+6K133837Viora V-TotalViora, Ltd.201433—
+6K131142Genesis Led WandsGenesis Biosystems, Inc.20130—
+6K132431Thermage CPT SystemSolta Medical, Inc.2013171
+6K122493GenesisplusCutera, Inc.201318—
+6K122966XP200Btl Industries, Ltd.20131—
+6K130283Evrf SystemF Care Systems NV20132—
+6K121327Diolase 10SBiolase Technology, Inc.20132—
+6K120460SmartluxMedmix Co., Ltd.201218—
+6K113843Freedom ND: Yag Laser SystemLutronic Corporation20120—
+6K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc.20123—
+6K120527Alpha Orthopaedics AT2 SystemAlpha Orthopaedics, Inc.20120—
+6K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+6K112669Tattoostar Effect YAsclepion Laser Technologies GmbH20128—
+6K112334Vein-Gogh InstrumentRefine USA, LLC20120—
+6K101916Joule Multi-Platform SystemSciton, Inc2011111—
+6K101147Modified Alma Lasers Family of Accent Radiofrequency (RF) SystemAlma Lasers, Inc.20114—
+6K100586Venus Freeze SystemVenus Concept, Ltd.201031—
+6K102003Xpress Balloon DeviceEntellus Medical, Inc.201036—
+6K092734E-Light LineEspansione Marketing S.P.A20102—
+6K101967Non-Ablative Wrinkle Treatent Handpiece Modle Pelleve'Ellman Int'L, Inc.201053—
+6K093007Entellus Medical Balloon DeviceEntellus Medical, Inc.201041—
+6K090025Matrix RF ApplicatorSyneron Medical, Ltd.201018—
+6K082586Lightwave Professional DeluxeLightwave Technologies, LLC20104—
+6K090762LEDAQuantel Derma GmbH200946—
+6K083461Imagine TC Skin Therapy SystemEndymion Medical, Ltd.2009101—
+6K082834Ellman International Non-Ablative Technique for Surgitron IecEllman Int'L, Inc.2009561
+6K081307Omnilux Clear-UPhoto Therapeutics, Inc.2009169—
+6K082622Alma Lasers Accent B-Shape Massager Handpiece/ModuleAlma Lasers, Ltd.200945—
+6K082247Evis MD Platinum Red Light TherapyAgeless Beauty Corporation20081—
+6K073000LumaprobeClareblend, Inc.20080—
+6K073022Clareblend Led Probes Model# 7201-415, 7204-631, 7205-830Clareblend, Inc.20080—
+6K073572Matrix RF ApplicatorSyneron Medical, Ltd.2008102—
+6K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008266—
+6K072459Omnilux New-UPhoto Therapeutics, Inc.200891—