510(k) Report

Devices descending from K040662

118 later devices reach Vectra Genisys (Module & Transportable) and Intelect XT (Module &… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150353BTL-4000BTL Industries, Inc.20150—
+1K141564Opton ProZimmer Medizinsystems GmbH20140—
+1K132284Vectra Neo Clinical Therapy SystemDjo, LLC201414—
+1K081962Lapex BCSMeridian Co., Ltd.200819—
+1K082969Luminex Infrared Lamp SystemMedical Laser Systems, Inc.20081—
+1K073352Weberneedle Basic LaserWeber Medical GmbH20080—
+1K070516PowerlaserPowermedic Aps200763—
+1K053473Maestro MDTL Laser SystemAdvanced Medical Technologies, Inc.20068—
+1K052647Clini-Lase System, Models CL-Base, CL-2000, CL-1200, CL-500, CL-300, CL-275, CL-155…American Spine Center, Ltd.20052—
+1K050070K-Laser, Models 3,4,4D,6DEltech S.R.L200512—
+2K192249InMode System with Tone ApplicatorInMode, Ltd.20199—
+2K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+2K153696Chattanooga Revolution WirelessDjo, LLC20163—
+2K132529Gallieon-1 Medical LaserFuture Device and Technology, Inc.20140—
+2K134017GigalaserPowermedic Aps20141—
+2K123177Stimlase 2000 Low Level Laser Therapy SystemLaserstim, Inc.20130—
+2K110342Yolo CurveYolo Medical, Inc.20110—
+2K102375LUCIAMeridian Co., Ltd.20111—
+2K101366I-Lipo, Models A00-1238 (230V), A00-1239 (120V)Chromogenex Technologies, Ltd.201016—
+2K091497K-Laser K-1200, Model 12 WEltech S.R.L20097—
+2K083595EzlaseBiolase Technology, Inc.200958—
+2K083560Expanded Spectrum Photo Therapy Device, Model Espt-3XLighthouse Technical Innovations, Inc.20081—
+2K080786ML830TPMicrolight Corporation of America20080—
+2K070400LC Therapy, Model LCT-1000Litecure, LLC20078—
+2K061656Laser-D68Laser Pain Clinics LP20065—
+2K060134Apollo IR Heat Lamp SystemApollo Physical Therapy Products International200611
+3K210674Shoulder PacemakerNcs Lab Srl20211—
+3K202186TrueRelief DeviceTruerelief20210—
+3K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd.20216—
+3K202079PhysiqEl.En Electronic Engineering Spa20201—
+3K150466ZX2 Laser SystemLzr7, Inc.20150—
+3K142340Infrared Therapy SystemBeijing Huatai Healthcare Technology Co., Ltd.20140—
+3K123971Cynosure 1064NM Diode LaserCynosure, Inc.201325—
+3K121286EPIC 10Biolase Technology, Inc.201231—
+3K120604K-LaserEltech S.R.L20124—
+3K111501I-Lipo SystemChromogenex Technologies Limited201215—
+3K103511Litecure Therapy SystemLitecure, LLC20110—
+4K241433EVE Synergy (EVE-20M)Weero Co., Ltd.20251—
+4K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+4K232334Deka SimonEl.En S.P.A.20230—
+4K220994Shoulder PacemakerTMNcs Lab Srl20220—
+4K210877Evolve System with the T3 ApplicatorInMode, Ltd.20215—
+4K192430Epic 980Biolase, Inc.20195—
+4K180967Dental Diode Laser SystemLazon Medical Laser Co., Ltd.20180—
+4K171087AXON IR Heat LampCrystal Medtech, LLC20170—
+4K170500SIROLaser Advance+Dentsply Sirona201721—
+4K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.20163—
+4K161198Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3Usa Laser Biotech, Inc.20160—
+4K160947LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX…Usa Laser Biotech, Inc.20160—
+4K151521Phoenix Thera-Lase SystemPhoenix Thera-Lase Systems, LLC20150—
+4K150724SculpSureCynosure, Inc.201521—
+4K150230SculpSureCynosure, Inc.201521—
+4K143741Lipofina Laser SystemYolo Medical, Inc.20153—
+4K130341Strawberry, Strawberry & CreamLaser Lipo Limited201312—
+5K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.20260—
+5K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+5K232222Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)Medency S.R.L.20230—
+5K230167BACK 4Swims America Corp20230—
+5K230037BACK 3Swims America Corp20230—
+5K213534PHantom TrilogyResurgeonz, LLC20220—
+5K210367D-Laser Blue, D-Laser 16Guilin Woodpecker Medical Instrument Co., Ltd.20226—
+5K202955Contour Light CL-100Contour Research, LLC20218—
+5K200693K2 MobileHulaser, Inc.20202—
+5K192275invisa-RED ELITEIR Technology, LLC20201—
+5K193656SkyPulseFotona D.O.O.202011—
+5K193486Epic 980Biolase, Inc.20202—
+5K191068Powersculp laser lipolysis systemWuhan Lotuxs Technology Co., Ltd.20196—
+5K180044SIROLaser BlueDentsply Sirona201812—
+5K170709CURVE Laser SystemYolo Medical, Inc.20170—
+5K160470SculpSureCynosure, Inc.201620—
+5K134040BTL-9000; BTL-9000 Radiofrequency ModuleBtl Industries, Ltd.20140—
+6K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+6K260688Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+6K243854Contour Light (CL-100)Contour Research, LLC20261—
+6K252786Led Light Phototherapy Bed (Pro 450/ GY-680A)Shenzhen Suyzeko Limited.20250—
+6K250731MateLaser Medical Diode Laser Systems (ML-DLS-30)Matelaser, Inc.20250—
+6K243764Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)Wuhan Pioon Technology Co., Ltd.20250—
+6K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+6K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+6K234085LUNE™ PureHygieneEnamel Pure20241—
+6K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+6K230047Medical Diode Laser SystemsGigaalaser Company, Ltd.20242—
+6K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+6K232977Biophotas Celluma CONTOURBiophotas, Inc.20235—
+6K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+6K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+6K222265DiosculptShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20220—
+6K211681EONDominion Aesthetic Technologies, Inc.20221—
+6K212331BodySculpRohrer Aesthetics, LLC20211—
+6K211402Powersculp laser lipolysis systemLotuxs Medtech (Suzhou) Co., Ltd.20210—
+6K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+6K201387Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc.20210—
+6K201731Diode Laser Body Sculpture SystemShanghai Apolo Medical Technology Co., Ltd.20201—
+6K190743Venus BlissVenus Concept USA, Inc.20194—
+6K171111SculpsureCynosure, Inc.201710—
+7K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+7K260138LUNE PureHygieneEnamel Pure20260—
+7K260129Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )Shenzhen Kaiyan Medical Equipment Co., Ltd.20261—
+7K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+7K251781Kala Mini 2.0 (Kala-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—