510(k) Report

Devices descending from K033923

109 later devices reach TH0R Ddii IR Lamp System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081962Lapex BCSMeridian Co., Ltd.200819—
+1K082969Luminex Infrared Lamp SystemMedical Laser Systems, Inc.20081—
+1K073352Weberneedle Basic LaserWeber Medical GmbH20080—
+1K070024Thor VR Single Diode Laser Treatment Probe, Model 200 MW Single VR Diode ProbeThor International200777—
+1K060134Apollo IR Heat Lamp SystemApollo Physical Therapy Products International200611
+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—
+2K170500SIROLaser Advance+Dentsply Sirona201721—
+2K150466ZX2 Laser SystemLzr7, Inc.20150—
+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—
+2K100143Pilot Diode Laser, Model 002-00139CAO Group, Inc.201020—
+2K083595EzlaseBiolase Technology, Inc.200958—
+2K080786ML830TPMicrolight Corporation of America20080—
+2K061656Laser-D68Laser Pain Clinics LP20065—
+3K210367D-Laser Blue, D-Laser 16Guilin Woodpecker Medical Instrument Co., Ltd.20226—
+3K193656SkyPulseFotona D.O.O.202011—
+3K180044SIROLaser BlueDentsply Sirona201812—
+3K131059Pioneer Elite Diode LaserCAO Group, Inc.20132—
+3K123443Precise SHP Diode LaserCAO Group, Inc.20139—
+3K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+3K123971Cynosure 1064NM Diode LaserCynosure, Inc.201325—
+3K121286EPIC 10Biolase Technology, Inc.201231—
+3K120604K-LaserEltech S.R.L20124—
+3K111501I-Lipo SystemChromogenex Technologies Limited201215—
+4K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+4K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+4K250731MateLaser Medical Diode Laser Systems (ML-DLS-30)Matelaser, Inc.20250—
+4K243764Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)Wuhan Pioon Technology Co., Ltd.20250—
+4K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+4K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+4K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+4K230047Medical Diode Laser SystemsGigaalaser Company, Ltd.20242—
+4K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+4K232222Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)Medency S.R.L.20230—
+4K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+4K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+4K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+4K192430Epic 980Biolase, Inc.20195—
+4K181602Pioneer Elite Diode LaserCAO Group, Inc.20190—
+4K181601Precise SHP Diode LaserCAO Group, Inc.20191—
+4K180967Dental Diode Laser SystemLazon Medical Laser Co., Ltd.20180—
+4K171986Sterling Supreme Diode LaserCAO Group, Inc.20171—
+4K171087AXON IR Heat LampCrystal Medtech, LLC20170—
+4K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.20163—
+4K161198Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3Usa Laser Biotech, Inc.20160—
+4K152461The Time Machine Series LasersMedical Lasers Manufacturer, 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—
+4K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+4K151521Phoenix Thera-Lase SystemPhoenix Thera-Lase Systems, LLC20150—
+4K150724SculpSureCynosure, Inc.201521—
+4K150230SculpSureCynosure, Inc.201521—
+4K143741Lipofina Laser SystemYolo Medical, Inc.20153—
+4K142226Pilot Ultra Diode LaserCAO Group, Inc.20140—
+4K142225Pilot Elite Diode LaserCAO Group, Inc.20140—
+4K130341Strawberry, Strawberry & CreamLaser Lipo Limited201312—
+5K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.20260—
+5K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+5K254197Picasso Pro Diode Laser (002-00460)CAO Group, Inc.20260—
+5K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+5K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+5K242755Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE…Gigaalaser Company, Ltd.20251—
+5K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+5K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+5K213534PHantom TrilogyResurgeonz, LLC20220—
+5K202955Contour Light CL-100Contour Research, LLC20218—
+5K200693K2 MobileHulaser, Inc.20202—
+5K192275invisa-RED ELITEIR Technology, LLC20201—
+5K193486Epic 980Biolase, Inc.20202—
+5K181614Sterling Supreme Diode LaserCAO Group, Inc.20190—
+5K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+5K191068Powersculp laser lipolysis systemWuhan Lotuxs Technology Co., Ltd.20196—
+5K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+5K170709CURVE Laser SystemYolo Medical, Inc.20170—
+5K160470SculpSureCynosure, Inc.201620—
+5K134040BTL-9000; BTL-9000 Radiofrequency ModuleBtl Industries, Ltd.20140—
+6K260688Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+6K253965CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight…Wuhan PHOMED Technology Company, Ltd.20260—
+6K243854Contour Light (CL-100)Contour Research, LLC20261—
+6K252786Led Light Phototherapy Bed (Pro 450/ GY-680A)Shenzhen Suyzeko Limited.20250—
+6K234085LUNE™ PureHygieneEnamel Pure20241—
+6K232977Biophotas Celluma CONTOURBiophotas, Inc.20235—
+6K222265DiosculptShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20220—
+6K211681EONDominion Aesthetic Technologies, Inc.20221—
+6K212331BodySculpRohrer Aesthetics, LLC20211—
+6K211402Powersculp laser lipolysis systemLotuxs Medtech (Suzhou) Co., Ltd.20210—
+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—
+7K260138LUNE PureHygieneEnamel Pure20260—
+7K260129Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )Shenzhen Kaiyan Medical Equipment Co., Ltd.20261—
+7K251781Kala Mini 2.0 (Kala-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+7K241947EnergyLounger (TY-01)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+7K233099GladiatorRohrer Aesthetics, LLC20240—
+7K2406581060nm laser body slimming machineHebei JT Medical Co., Ltd.20240—
+7K233962ReBorn (1050nm)Lightfective, Ltd.20240—
+7K222226EONDominion Aesthetic Technologies, Inc.20230—