510(k) Report

Devices descending from K950239

1,329 later devices reach Sensimatic 500SE through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K082247Evis MD Platinum Red Light TherapyAgeless Beauty Corporation20081—
+7K073000LumaprobeClareblend, Inc.20080—
+7K073022Clareblend Led Probes Model# 7201-415, 7204-631, 7205-830Clareblend, Inc.20080—
+7K073572Matrix RF ApplicatorSyneron Medical, Ltd.2008102—
+7K081015Ceralas D 980NM Diode Laser, Models D15 and D25Biolitec, Inc.200834—
+7K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008266—
+7K080104Vari-Lase Endovenous Laser Console, Model 7542Vascular Solutions, Inc.20080—
+7K072459Omnilux New-UPhoto Therapeutics, Inc.200891—
+7K072699Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models: Accent, Accent XLAlma Lasers, Ltd.200784—
+7K072152Juniper CLN1 Dermal Cooling DeviceJuniper Medical, Inc.200734—
+7K072106150W Ceralas D 980NM Diode LaserBiolitec, Inc.2007229—
+7K071786Portrait PSRRhytec Incorporated2007109—
+7K071295100W Ceralas D 980NM Diode LaserBiolitec, Inc.2007230—
+7K070388Profile Multi-Platform SystemSciton, Inc2007129—
+7K063396Velure Family of Diode Lasers and Delivery Device AccessoriesLasering S.R.L.200722—
+7K060792IllumimedPhotoactif, LLC2006115—
+7K063538Arthrocare Controller (System 2000 and 8000), Arthrocare Patient Cable, Foot Control…Arthrocare Corp.200640—
+7K060448Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd.2006297—
+7K061117Nanolite Skin Care SystemNanolite Technology, Inc.20060—
+7K052778Thermage Thermacool Skin MarketingThermage, Inc.2005130—
+7K051259Versaclear Skin Therapy System, Model 100Theralight, Inc.200547—
+7K052324Polaris LV, Lva ApplicatorSyneron Medical, Ltd.2005456—
+7K050216Omnilux Revive and Omnilux PlusPhoto Therapeutics Limited2005160—
+7K051255Lumiphase-ROpusmed, Inc.2005143—
+7K050397Velasmooth, ShaperSyneron Medical, Ltd.2005150—
+7K050452Aurora SR and Sra ApplicatorSyneron Medical, Ltd.2005301—
+7K043575Dermillume, Model PRO1000Care Electronics, Inc.20054—
+7K041959Polaris DS/CometSyneron Medical, Ltd.2004301—
+7K032514AC Applicator, Aurora ACSyneron Medical, Ltd.20041—
+7K033586Modification to Aurora DSSyneron Medical, Ltd.2003303—
+7K031671Polaris WRSyneron Medical, Ltd.2003678—
+8K253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.20260—
+8K261964Echolaser X4Elesta S.P.A20260—
+8K253480Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L.20260—
+8K254056THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35…Olympus Medical Systems Corp.20260—
+8K253484Lutronic GeniusCynosure Lutronic Technology Corporation20260—
+8K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+8K260632Laser Thermal Therapy KitElesta S.P.A20260—
+8K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+8K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+8K252658Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd.20251—
+8K252704F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB, 06Pedal1St)F Care Systems USA, LLC20250—
+8K250852CoolfaseAsterasys Co., Ltd.20250—
+8K252150Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410)…Olympus Medical Systems Corporation202504
+8K250261Heager Medical Laser Family (Sabrina/Adolf)Heager GmbH20250—
+8K251327XERFLutronic Corporation202501
+8K240857Youmagic FLM System (YM5-U1)We Medical Technology (Wuxi) Co., Ltd.20250—
+8K242241SunnyShenB Co., Ltd.20250—
+8K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) Co., Ltd.20250—
+8K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+8K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+8K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+8K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+8K242688Finiff SystemSkingrab Co., Ltd.20240—
+8K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+8K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—
+8K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+8K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+8K240248Volnewmer™Classys, Inc.20241—
+8K233849BTL-499BTL Industries, Inc.20240—
+8K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+8K233604BTL-785SBTL Industries, Inc.20243—
+8K233024Alma HarmonyAlma Lasers, Inc.20241—
+8K23299210THERMATentech, Inc.20230—
+8K231777Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories…Olympus Winter & Ibe GmbH202302
+8K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd.20230—
+8K230663DensityJeisys Medical, Inc.20232—
+8K230308Alma HarmonyAlma Lasers, Inc.20232—
+8K220214Painless IPL System - KDT750Shanghai Omni Laser Skinology Co., Ltd.20230—
+8K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+8K222701MANTA LaserSqualus Med, Ltd.20222—
+8K221989The OligioWontech Co., Ltd.20222—
+8K213761Joule diVa SystemSciton, Inc20220—
+8K221571InMode Multi-systemInMode, Ltd.20222—
+8K213594Echolaser X4Elesta S.P.A20221—
+8K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+8K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+8K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+8K203277Electrosurgical Generator ESG-410, Foot Switches, PK Cutting ForcepsOlympus Winter & Ibe GmbH202114
+8K193070VIVACE Electrosurgical DeviceShenB Co., Ltd.20214—
+8K203054FlexSysGme German Medical Engineering GmbH20210—
+8K202415VirtueRFShenB Co., Ltd.20213—
+8K202361UltraSlim Digital, UltraSmooth DigitalWard Photonics, LLC20200—
+8K192406AveCure BT Microwave Ablation SystemMedwaves, Inc.20200—
+8K200472Viveve SystemViveve Medical, Inc.20202—
+8K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+8K200427Sonicision Cordless Ultrasonic DissectorCovidien, LLC20200—
+8K192856MT OneM&T S.R.L.20202—
+8K200185Sylfirm XVIOL Co., Ltd.20202—
+8K193656SkyPulseFotona D.O.O.202011—
+8K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+8K192545PotenzaJeisys Medical Incorporated202020—
+8K183284INTRAcel RF Microneedle SystemJeisys Medical, Inc.20200—
+8K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—
+8K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+8K191693BC-5Reveallux, Corp20190—
+8K183708Poly ClearMedtek Skincare, LLC201922—
+8K182930PerioLase Nd:YAG Pulsed Dental Laser SystemMillennium Dental Technologies, Inc.20190—
+8K190938Phototherapy SystemShanghai Apolo Medical Technology Co., Ltd.201916—
+8K190422Viveve System 2.0Viveve Medical20194—