510(k) Report

Devices descending from K020017

187 later devices reach Medx 1000 Series through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K203826LaserCap Family of Lasers 300, 224, 120 & 80Transdermal Cap, Inc.20211—
+5K192430Epic 980Biolase, Inc.20195—
+5K182501Hair Laser HeadbandPulsaderm, LLC20180—
+5K180967Dental Diode Laser SystemLazon Medical Laser Co., Ltd.20180—
+5K180885HairMax LaserLexington International, LLC20185—
+5K180460Theradome LH40Theradome, Inc.20180—
+5K173846DermaScalp Laser CapDermascalp, LLC20181—
+5K173843illumiflow 148 Laser CapEglobal, LLC20180—
+5K170500SIROLaser Advance+Dentsply Sirona201721—
+5K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.20163—
+5K162994Capillus302, Capillus312, Capillus352Capillus, LLC20161—
+5K161198Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3Usa Laser Biotech, Inc.20160—
+5K160947LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX…Usa Laser Biotech, Inc.20160—
+5K152587DermaScalp Laser CapDermascalp, LLC20160—
+5K153618Capillus202Capillus, LLC201644—
+5K150724SculpSureCynosure, Inc.201521—
+5K150230SculpSureCynosure, Inc.201521—
+5K141564Opton ProZimmer Medizinsystems GmbH20140—
+5K120604K-LaserEltech S.R.L20124—
+5K102278Quadra Bloc Tens PlusGradient Technologies, LLC20110—
+5K103511Litecure Therapy SystemLitecure, LLC20110—
+6K262183Hair Growth Helmet (TK-176, TK-600, TK-500, TK-282, TK-500A, TK-282A, TK-126, TK-60)Shenzhen Nuon Medical Equipment Co., Ltd.20260—
+6K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.20260—
+6K261675CHZL Red Light Therapy Hair Growth Cap (Model…Shenzhen Chuanghong Zhilian Technology Co., Ltd.20260—
+6K253669Trudermal Halo Hair Growth System (M-180A); Aduro Hair Growth (M-130,M-300)Shenzhen Kaiyan Medical Equipment Co., Ltd.20261—
+6K251594truFlexSyrma Johari Medtech Limited20250—
+6K251017CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+6K250467Red Light Hair Growth Cap (LP-RJVGRW-BLK)Shenzhen Idea Light Limited20250—
+6K241342Hair Growth Comb (SZ-23,SZ-23A)Shenzhen Nuon Medical Equipment Co., Ltd.20240—
+6K241685SofWave SystemSofwave Medical, Ltd.20242—
+6K232222Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)Medency S.R.L.20230—
+6K232356Laser Cap, Model: Hat-01Hubei Yjt Technology Co.,Ltd20230—
+6K231321Nooance Led And Laser HelmetShenzhen Kaiyan Medical Equipment Co., Ltd.20231—
+6K230597Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B)Light Tree Ventures Europe B.V.20232—
+6K210367D-Laser Blue, D-Laser 16Guilin Woodpecker Medical Instrument Co., Ltd.20226—
+6K200693K2 MobileHulaser, Inc.20202—
+6K200929Hair Growth SystemXuzhou Kernel Medical Equipment Co., Ltd.20200—
+6K192552Irradiation Cosmetic DeviceChongqing Peninsula Medical Technology Co., Ltd.20202—
+6K193486Epic 980Biolase, Inc.20202—
+6K190467iHelmet Hair Growth SystemSlinph Technologies Co., Ltd.20196—
+6K191068Powersculp laser lipolysis systemWuhan Lotuxs Technology Co., Ltd.20196—
+6K182562Hair Boom 69Wontech20184—
+6K180044SIROLaser BlueDentsply Sirona201812—
+6K171835Irradiation Aesthetic DeviceChongqing Peninsula Medical Technology Co., Ltd.20185—
+6K171087AXON IR Heat LampCrystal Medtech, LLC20170—
+6K162782iHelmet Hair Growth SystemSlinph Technologies Co., Ltd.201722—
+6K160470SculpSureCynosure, Inc.201620—
+6K151521Phoenix Thera-Lase SystemPhoenix Thera-Lase Systems, LLC20150—
+7K260899Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157…Zdeer Technology (Henan) Co., Ltd.20260—
+7K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+7K252053VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343F, TB-2442F)Touchbeauty Beauty & Health ( Shenzhen ) Co., Ltd20250—
+7K250731MateLaser Medical Diode Laser Systems (ML-DLS-30)Matelaser, Inc.20250—
+7K243764Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)Wuhan Pioon Technology Co., Ltd.20250—
+7K250308Hair Growth Device (KCA441-200, KCA441-120, KCA441-88, KCA441-56, KCA441-200S…Dongguan Boyuan Intelligent Technology Co.,Ltd20251—
+7K250146SofWave SystemSofwave Medical, Ltd.20251—
+7K234085LUNE™ PureHygieneEnamel Pure20241—
+7K230047Medical Diode Laser SystemsGigaalaser Company, Ltd.20242—
+7K222265DiosculptShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20220—
+7K211681EONDominion Aesthetic Technologies, Inc.20221—
+7K212331BodySculpRohrer Aesthetics, LLC20211—
+7K211402Powersculp laser lipolysis systemLotuxs Medtech (Suzhou) Co., Ltd.20210—
+7K201387Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc.20210—
+7K201731Diode Laser Body Sculpture SystemShanghai Apolo Medical Technology Co., Ltd.20201—
+7K192627Laser Hair Growth CapShang FA Biotechnology Co.20191—
+7K191154Hair Boom 69Wontech20193—
+7K190743Venus BlissVenus Concept USA, Inc.20194—
+7K171111SculpsureCynosure, Inc.201710—
+8K261253Laser Hair Growth Devices (HR-H1, HR-H2, HR-H3, HR-H4, HR-H5, HR-H6, HR-H7, HR-H8…Ziree Co., Ltd.20260—
+8K260138LUNE PureHygieneEnamel Pure20260—
+8K251746Pure ImpactSofwave Medical, Ltd.20250—
+8K242755Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE…Gigaalaser Company, Ltd.20251—
+8K233099GladiatorRohrer Aesthetics, LLC20240—
+8K2406581060nm laser body slimming machineHebei JT Medical Co., Ltd.20240—
+8K233962ReBorn (1050nm)Lightfective, Ltd.20240—
+8K222226EONDominion Aesthetic Technologies, Inc.20230—
+8K213308Venus BlissMAXVenus Concept USA, Inc.20222—
+8K192970SlimusHironic Co., Ltd.20200—
+8K192425Hair Boom 69, Hair Boom Air, Ulike Hair UpUpWontech Co., Ltd.20192—
+8K171992SculpSureCynosure, Inc.20178—
+9K253965CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight…Wuhan PHOMED Technology Company, Ltd.20260—
+9K231971Deka Physiq 360El.En S.P.A.20230—
+9K223862Hair Boom 69, Hair BoomAir, Hair Boom, Ulike Hair UpUpWontech Co., Ltd.20231—
+9K220592Venus BlissMAXVenus Concept USA, Inc.20221—
+9K182741SculpSureCynosure20195—
+10K252845Venus Nova (FP-2001)Venus Concept, Inc.20250—
+10K240064Hair Boom Air / Ulike Hair UpUp / Hair Boom 69 / Hair BoomWontech Co., Ltd.20240—
+10K231131Diode Laser Body Sculpture SystemsShanghai Bele Medical Technology Co.,Ltd20230—