510(k) Report

Devices descending from K080318

184 later devices reach Alma Laser Nir Module through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+5K241860Diode Laser Hair Removal SystemBeijing Winkonlaser Technology Limited20240—
+5K240520Diode Laser Hair Removal System (SH-VD910)Beijing Sea Heart International Science and Technologyco.Ltd20240—
+5K234085LUNE™ PureHygieneEnamel Pure20241—
+5K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+5K230047Medical Diode Laser SystemsGigaalaser Company, Ltd.20242—
+5K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+5K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+5K223778Diode Laser Hair Removal System (RD-SLD600)Shanghai Omni Laser Skinology Co., Ltd.20230—
+5K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+5K222916US 450 Diode Laser EquipmentBeijing Globalipl Development Co., Ltd.20220—
+5K22079410PLTentech Co., Ltd.20220—
+5K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+5K222265DiosculptShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20220—
+5K212790XLase PlusBiotec Italia, Srl20220—
+5K211681EONDominion Aesthetic Technologies, Inc.20221—
+5K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+5K212478Dermatological diode laser systemBeijing Stelle Laser Technology Co., Ltd.20220—
+5K213225Diode Laser System GP900A8, Diode Laser System GP900Q8Shenzhen Gsd Tech Co., Ltd.20210—
+5K212331BodySculpRohrer Aesthetics, LLC20211—
+5K211402Powersculp laser lipolysis systemLotuxs Medtech (Suzhou) Co., Ltd.20210—
+5K211335Diode Laser Machine, Model Number: BM-100Zhengzhou Bestview ST Co., Ltd.20215—
+5K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+5K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+5K202257Dermatological Diode Laser SystemsZhuolu Jontelaser Manufacturing Technology Co., Ltd.20210—
+5K201387Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc.20210—
+5K202980Laser Therapy DeviceShenzhen Leaflife Technology Co., Ltd.20202—
+5K201731Diode Laser Body Sculpture SystemShanghai Apolo Medical Technology Co., Ltd.20201—
+5K200736Stardust MedI.T.S. Group S.R.L.20200—
+5K200616E>EyeCE-Swin20200—
+5K191970Diode Laser Hair Removal SystemBeijing Sano Laser S&T Development Co.,Ltd20200—
+5K193328IPL + Diode Laser MachineBeijing Globalipl Development Co., Ltd.20200—
+5K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+5K190743Venus BlissVenus Concept USA, Inc.20194—
+5K182924Diode Laser Treatment SystemWeifang KM Electronics Co., Ltd.20192—
+5K182604New EraStep UP Skin Laser, LLC201801
+5K180353Diode laser hair removal deviceZhengzhou PZ Laser Slim Technology Co., Ltd.201824—
+5K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+5K171111SculpsureCynosure, Inc.201710—
+6K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+6K262070Diode Laser Therapy Systems (DL612A)Hebei Zollvan Medical Technology Co., Ltd.20260—
+6K260138LUNE PureHygieneEnamel Pure20260—
+6K252427Diode Laser Hair Removal Machine (GLD01)Sanhe Meditech Co., Ltd.20250—
+6K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+6K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+6K242755Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE…Gigaalaser Company, Ltd.20251—
+6K242951Diode laser hair removal machine (QDTM-02)Beijing Nubway S&T Co., Ltd.20251—
+6K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+6K241547Diode Laser Therapy Device (DF-DIODE LASER-S1)Weifang Dragonfly Electronics Technology Co., Ltd.20240—
+6K241642Diode Laser Hair Removal System (MBT-Diode Laser)Beijing Mega Beauty Technology Co., Ltd.20240—
+6K233099GladiatorRohrer Aesthetics, LLC20240—
+6K2406581060nm laser body slimming machineHebei JT Medical Co., Ltd.20240—
+6K233962ReBorn (1050nm)Lightfective, Ltd.20240—
+6K222226EONDominion Aesthetic Technologies, Inc.20230—
+6K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+6K220381Diode Laser Therapy SystemsBeijing Lasertell Medical Co., Ltd.20221—
+6K220103LED Therapy Device (Planar LED/Planar LED mini)Shenzhen Leaflife Technology Co., Ltd.20221—
+6K213308Venus BlissMAXVenus Concept USA, Inc.20222—
+6K210168Diode Laser Therapy SystemsBeijing Kes Biology Technology Co., Ltd.20214—
+6K210663Dermatological Diode Laser SystemsBeijing HuaCheng Taike Technology Co., Ltd.20218—
+6K210033Laser Treatment System, Model: NYX and GraceCanadian Pioneer Medical Technology Corporation20211—
+6K192970SlimusHironic Co., Ltd.20200—
+6K192735Diode Laser Hair Removal MachineBeijing Lead Beauty S & T Co., Ltd.20202—
+6K171992SculpSureCynosure, Inc.20178—
+7K261693Diode laser hair removal machine (QDTM-04)Beijing Nubway S&T Co., Ltd.20260—
+7K253965CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight…Wuhan PHOMED Technology Company, Ltd.20260—
+7K251457Diode laser therapy device (VADER)Beijing Superlaser Technology Co., Ltd.20250—
+7K232709Diode laser therapy deviceHebei Zhemai Technology Co., Ltd.20231—
+7K231901Hakon, Hakon SmartMedical San Indústria DE Equipamentos Médicos Ltda.20230—
+7K231971Deka Physiq 360El.En S.P.A.20230—
+7K230362Planar LED mateShenzhen Leaflife Technology Co., Ltd.20230—
+7K221312Diode Laser Hair Removal DeviceGuangzhou Chuang Zao Mei Technology Co., Ltd.20224—
+7K220592Venus BlissMAXVenus Concept USA, Inc.20221—
+7K212978Diode laser therapy systemBeijing Unt Technology Co., Ltd.20211—
+7K212793Laser Treatment System, Model: Hera, ArmoCanadian Pioneer Medical Technology Corporation20210—
+7K182741SculpSureCynosure20195—
+8K260307Diode Laser Therapy Systems (V19)Weifang Mingliang Electronics Co., Ltd.20260—
+8K252845Venus Nova (FP-2001)Venus Concept, Inc.20250—
+8K251801Diode laser device (BM091)Hebei Newangie Technology Co., Ltd.20250—
+8K250431Medical Diode Laser Hair Removal System (MNLT-D1)Shandong Moonlight Electronics Tech Co., Ltd.20251—
+8K243465Diode Laser Hair Removal Device (EVOLUTION MEDICAL); Diode Laser Hair Removal Device…Guangzhou Chuang Zao Mei Technology Co., Ltd.20250—
+8K241498Diode laser Treatment System (K18)Hebei Keylaser Sci-Tech Co.,Ltd20240—
+8K231131Diode Laser Body Sculpture SystemsShanghai Bele Medical Technology Co.,Ltd20230—
+9K252048808nm semiconductor laser hair removal machineXi'An Taibo Electronic Technology Co., Ltd.20260—