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
+6K072699Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models: Accent, Accent XLAlma Lasers, Ltd.200784—
+6K072152Juniper CLN1 Dermal Cooling DeviceJuniper Medical, Inc.200734—
+6K071786Portrait PSRRhytec Incorporated2007109—
+6K070388Profile Multi-Platform SystemSciton, Inc2007129—
+6K060792IllumimedPhotoactif, LLC2006115—
+6K063538Arthrocare Controller (System 2000 and 8000), Arthrocare Patient Cable, Foot Control…Arthrocare Corp.200640—
+6K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are…Intermedic Arfran, SA2006299—
+6K060448Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd.2006297—
+6K061117Nanolite Skin Care SystemNanolite Technology, Inc.20060—
+6K052778Thermage Thermacool Skin MarketingThermage, Inc.2005130—
+6K051259Versaclear Skin Therapy System, Model 100Theralight, Inc.200547—
+6K050216Omnilux Revive and Omnilux PlusPhoto Therapeutics Limited2005160—
+6K051255Lumiphase-ROpusmed, Inc.2005143—
+6K050397Velasmooth, ShaperSyneron Medical, Ltd.2005150—
+6K050452Aurora SR and Sra ApplicatorSyneron Medical, Ltd.2005301—
+6K043575Dermillume, Model PRO1000Care Electronics, Inc.20054—
+6K041959Polaris DS/CometSyneron Medical, Ltd.2004301—
+6K032514AC Applicator, Aurora ACSyneron Medical, Ltd.20041—
+6K033586Modification to Aurora DSSyneron Medical, Ltd.2003303—
+6K031671Polaris WRSyneron Medical, Ltd.2003678—
+6K030186Polris LVSyneron Medical, Ltd.2003680—
+7K253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.20260—
+7K253480Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L.20260—
+7K254056THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35…Olympus Medical Systems Corp.20260—
+7K253484Lutronic GeniusCynosure Lutronic Technology Corporation20260—
+7K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+7K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+7K252745Halo Sterile Single-use Radial Fiber…Micro-Energy Medical Technology Co., Ltd.20251—
+7K252704F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB, 06Pedal1St)F Care Systems USA, LLC20250—
+7K253007Laser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); Laser Fiber (PT-OF-C-S); Laser Fiber…Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.20250—
+7K250852CoolfaseAsterasys Co., Ltd.20250—
+7K252150Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410)…Olympus Medical Systems Corporation202504
+7K252316Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100)Venclose, Inc.20250—
+7K251327XERFLutronic Corporation202501
+7K240857Youmagic FLM System (YM5-U1)We Medical Technology (Wuxi) Co., Ltd.20250—
+7K243630Medical Laser System Incanto / Evoline Platinum /EvolineSolar LS Cjsc20250—
+7K242241SunnyShenB Co., Ltd.20250—
+7K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) Co., Ltd.20250—
+7K250113neoLaser Laser Surgery FibersG.N.S Neolaser, Ltd.20250—
+7K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+7K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+7K242688Finiff SystemSkingrab Co., Ltd.20240—
+7K242251Litho 60; Litho 100; Litho 150Quanta System Spa20240—
+7K242191SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed…Olympus Surgical Technologies America202437
+7K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+7K233344Regenalase Laser SystemIpg Medical20240—
+7K240248Volnewmer™Classys, Inc.20241—
+7K233849BTL-499BTL Industries, Inc.20240—
+7K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+7K233604BTL-785SBTL Industries, Inc.20243—
+7K232568IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and AccessoriesIpg Medical Corporation202411
+7K233024Alma HarmonyAlma Lasers, Inc.20241—
+7K23299210THERMATentech, Inc.20230—
+7K231777Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories…Olympus Winter & Ibe GmbH202302
+7K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd.20230—
+7K231054V-LaserWontech Co., Ltd.20231—
+7K230663DensityJeisys Medical, Inc.20232—
+7K230308Alma HarmonyAlma Lasers, Inc.20232—
+7K220214Painless IPL System - KDT750Shanghai Omni Laser Skinology Co., Ltd.20230—
+7K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+7K223540AvalancheLase FamilyFotona D.O.O.20230—
+7K221989The OligioWontech Co., Ltd.20222—
+7K213761Joule diVa SystemSciton, Inc20220—
+7K221571InMode Multi-systemInMode, Ltd.20222—
+7K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+7K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+7K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+7K203277Electrosurgical Generator ESG-410, Foot Switches, PK Cutting ForcepsOlympus Winter & Ibe GmbH202114
+7K193070VIVACE Electrosurgical DeviceShenB Co., Ltd.20214—
+7K203788DermaV Laser SystemLutronic Corporation202101
+7K203054FlexSysGme German Medical Engineering GmbH20210—
+7K202415VirtueRFShenB Co., Ltd.20213—
+7K202361UltraSlim Digital, UltraSmooth DigitalWard Photonics, LLC20200—
+7K192406AveCure BT Microwave Ablation SystemMedwaves, Inc.20200—
+7K200472Viveve SystemViveve Medical, Inc.20202—
+7K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+7K200427Sonicision Cordless Ultrasonic DissectorCovidien, LLC20200—
+7K201455Litho 150, Cyber Ho 150Quanta System Spa20203—
+7K192856MT OneM&T S.R.L.20202—
+7K200185Sylfirm XVIOL Co., Ltd.20202—
+7K193656SkyPulseFotona D.O.O.202011—
+7K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+7K192545PotenzaJeisys Medical Incorporated202020—
+7K183284INTRAcel RF Microneedle SystemJeisys Medical, Inc.20200—
+7K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—
+7K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+7K191693BC-5Reveallux, Corp20190—
+7K183708Poly ClearMedtek Skincare, LLC201922—
+7K190938Phototherapy SystemShanghai Apolo Medical Technology Co., Ltd.201916—
+7K190422Viveve System 2.0Viveve Medical20194—
+7K183156V-LaserWontech Co., Ltd.20193—
+7K182497OsteoCool RF Ablation SystemMedtronic Sofamor Danek USA, Inc.20195—
+7K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+7K181838Sinusway Dilation System3nt Medical, Ltd.20180—
+7K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+7K181518Sebacia MicroparticlesSebacia, Inc.20180—
+7K173627Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic DissectorSurgical Instrument Service and Savings, Inc.20180—
+7K180900LED Light Therapy DeviceUvbiotek, LLC201829—
+7K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+7K173692D-Actor 200 Vibration Massage SystemStorz Medical AG20186—