510(k) Report

Devices descending from K070024

77 later devices reach Thor VR Single Diode Laser Treatment Probe, Model 200 MW Single VR Diode Probe through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170500SIROLaser Advance+Dentsply Sirona201721—
+1K100143Pilot Diode Laser, Model 002-00139CAO Group, Inc.201020—
+1K083595EzlaseBiolase Technology, Inc.200958—
+1K080786ML830TPMicrolight Corporation of America20080—
+2K210367D-Laser Blue, D-Laser 16Guilin Woodpecker Medical Instrument Co., Ltd.20226—
+2K193656SkyPulseFotona D.O.O.202011—
+2K180044SIROLaser BlueDentsply Sirona201812—
+2K131059Pioneer Elite Diode LaserCAO Group, Inc.20132—
+2K123443Precise SHP Diode LaserCAO Group, Inc.20139—
+2K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+2K123971Cynosure 1064NM Diode LaserCynosure, Inc.201325—
+2K121286EPIC 10Biolase Technology, Inc.201231—
+3K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+3K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+3K250731MateLaser Medical Diode Laser Systems (ML-DLS-30)Matelaser, Inc.20250—
+3K243764Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)Wuhan Pioon Technology Co., Ltd.20250—
+3K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+3K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+3K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+3K230047Medical Diode Laser SystemsGigaalaser Company, Ltd.20242—
+3K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+3K232222Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)Medency S.R.L.20230—
+3K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+3K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+3K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+3K192430Epic 980Biolase, Inc.20195—
+3K181602Pioneer Elite Diode LaserCAO Group, Inc.20190—
+3K181601Precise SHP Diode LaserCAO Group, Inc.20191—
+3K180967Dental Diode Laser SystemLazon Medical Laser Co., Ltd.20180—
+3K171986Sterling Supreme Diode LaserCAO Group, Inc.20171—
+3K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.20163—
+3K161198Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3Usa Laser Biotech, Inc.20160—
+3K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+3K160947LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX…Usa Laser Biotech, Inc.20160—
+3K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+3K150724SculpSureCynosure, Inc.201521—
+3K150230SculpSureCynosure, Inc.201521—
+3K142226Pilot Ultra Diode LaserCAO Group, Inc.20140—
+3K142225Pilot Elite Diode LaserCAO Group, Inc.20140—
+4K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.20260—
+4K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+4K254197Picasso Pro Diode Laser (002-00460)CAO Group, Inc.20260—
+4K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+4K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+4K242755Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE…Gigaalaser Company, Ltd.20251—
+4K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+4K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+4K200693K2 MobileHulaser, Inc.20202—
+4K193486Epic 980Biolase, Inc.20202—
+4K181614Sterling Supreme Diode LaserCAO Group, Inc.20190—
+4K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+4K191068Powersculp laser lipolysis systemWuhan Lotuxs Technology Co., Ltd.20196—
+4K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+4K160470SculpSureCynosure, Inc.201620—
+5K253965CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight…Wuhan PHOMED Technology Company, Ltd.20260—
+5K234085LUNE™ PureHygieneEnamel Pure20241—
+5K222265DiosculptShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20220—
+5K211681EONDominion Aesthetic Technologies, Inc.20221—
+5K212331BodySculpRohrer Aesthetics, LLC20211—
+5K211402Powersculp laser lipolysis systemLotuxs Medtech (Suzhou) Co., Ltd.20210—
+5K201387Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc.20210—
+5K201731Diode Laser Body Sculpture SystemShanghai Apolo Medical Technology Co., Ltd.20201—
+5K190743Venus BlissVenus Concept USA, Inc.20194—
+5K171111SculpsureCynosure, Inc.201710—
+6K260138LUNE PureHygieneEnamel Pure20260—
+6K233099GladiatorRohrer Aesthetics, LLC20240—
+6K2406581060nm laser body slimming machineHebei JT Medical Co., Ltd.20240—
+6K233962ReBorn (1050nm)Lightfective, Ltd.20240—
+6K222226EONDominion Aesthetic Technologies, Inc.20230—
+6K213308Venus BlissMAXVenus Concept USA, Inc.20222—
+6K192970SlimusHironic Co., Ltd.20200—
+6K171992SculpSureCynosure, Inc.20178—
+7K231971Deka Physiq 360El.En S.P.A.20230—
+7K220592Venus BlissMAXVenus Concept USA, Inc.20221—
+7K182741SculpSureCynosure20195—
+8K252845Venus Nova (FP-2001)Venus Concept, Inc.20250—
+8K231131Diode Laser Body Sculpture SystemsShanghai Bele Medical Technology Co.,Ltd20230—