510(k) Report

Devices descending from K001179

701 later devices reach Super Nova, Acubeam through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K170637sensiFirmEl Global Trade, Ltd.20173—
+7K162886Deka Motus AXEl.En Electronic Engineering Spa20171—
+7K162659Diode Laser Hair Removal SystemShandong Huamei Technology Co., Ltd.201740—
+7K170936Cutera enlighten III Laser SystemCutera, Inc.201710—
+7K162765Venus Velocity Diode Laser SystemVenus Concept, Ltd.20171—
+7K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.20161—
+7K161692Diode Laser Therapy MachineBeijing Adss Development Co., Ltd.20166—
+7K161981Olive PlusAma Network, Inc.20160—
+7K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+7K161043Profound SystemSyneron Candela Corporation20160—
+7K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+7K160470SculpSureCynosure, Inc.201620—
+7K153568InMode Plus SystemInmode MD, Ltd.201618—
+7K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+7K160368EVO platformQuanta System Spa201636—
+7K152012EVO platformQuanta System Spa201537—
+7K151473NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and…Focus Medical, LLC201537—
+7K142186Diode Laser Hair Removal SystemShenzhen Gsd Tech Co., Ltd.20151—
+7K142860Lumenis M22 SystemLumenis, Ltd.2015381
+7K141973Diode Laser Hair Removal SystemBeijing Anchorfree Technology Co., Ltd.201448—
+8K261370LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))Guangdong Newdermo Biotech Co., Ltd.20260—
+8K261601LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)Shenzhen Chuangtong Yigou Technology Co., Ltd.20260—
+8K261052LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA)Guangdong Newdermo Biotech Co., Ltd.20260—
+8K261253Laser Hair Growth Devices (HR-H1, HR-H2, HR-H3, HR-H4, HR-H5, HR-H6, HR-H7, HR-H8…Ziree Co., Ltd.20260—
+8K260946LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)Guangdong Newdermo Biotech Co., Ltd.20260—
+8K261570Picosure WorkstationCynosure, LLC20260—
+8K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+8K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+8K260150Led Facial Mask (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C)Nooance20260—
+8K254079LED Light Therapy Mask (Models: T2, RLD10)Shenzhen Desida Technology Co., Ltd.20260—
+8K251981Boston PICO (Boston PICO)Boston Aesthetics, Inc.20260—
+8K253712LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-052, RB-062, RB-072, RB-053, RB-063…Shenzhen Rainbow Technology Co., Ltd.20261—
+8K252369Boston Pico755Boston Aesthetics, Inc.20260—
+8K253086LED Light Therapy Device (Models: SG-FM, SG-FE)Sunglor Technology Co., Ltd.20250—
+8K252345Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd.20250—
+8K252264MEGELIN LED Light Therapy Mask (JML1, JML1+JML2); MEGELIN LED Light Therapy Mask (JML3…Shenzhen Zhenxing Ruitong Technology Co., Ltd.20252—
+8K250731MateLaser Medical Diode Laser Systems (ML-DLS-30)Matelaser, Inc.20250—
+8K252093Light Therapy Mask (1019055)Merchsource, LLC20250—
+8K251339Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03…Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+8K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+8K250880Led Light Mask (A093)Foshan Guangyu Weilai Medical Equipment Co., Ltd.20250—
+8K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+8K250581KALA Red Light Face Mask (KALA-01)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+8K243764Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)Wuhan Pioon Technology Co., Ltd.20250—
+8K244020Wrinkle Treatment Device (JM1, JM2B)Shenzhen Qianyu Technology Co., Ltd.20250—
+8K250146SofWave SystemSofwave Medical, Ltd.20251—
+8K250018Medical Diode Laser Systems (THEIA808)Gigaalaser Company, Ltd.20250—
+8K243630Medical Laser System Incanto / Evoline Platinum /EvolineSolar LS Cjsc20250—
+8K243957PicoalexWontech Co., Ltd.20250—
+8K242534HandPICO Fractional Laser Handpiece TipVydence Medical20241—
+8K241860Diode Laser Hair Removal SystemBeijing Winkonlaser Technology Limited20240—
+8K241407Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)Bios S.R.L.20240—
+8K240520Diode Laser Hair Removal System (SH-VD910)Beijing Sea Heart International Science and Technologyco.Ltd20240—
+8K240386Picosecond Nd:YAG Laser Systems (BL-C10)Shanghai Bele Medical Technology Co.,Ltd20240—
+8K234085LUNE™ PureHygieneEnamel Pure20241—
+8K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+8K230047Medical Diode Laser SystemsGigaalaser Company, Ltd.20242—
+8K230373HELIOS 785 PicoLaseroptek Co., Ltd.20232—
+8K230351LED Facial MaskShenzhen Sungpo Hi-Tech Electronic Co., Ltd.202333—
+8K223778Diode Laser Hair Removal System (RD-SLD600)Shanghai Omni Laser Skinology Co., Ltd.20230—
+8K222916US 450 Diode Laser EquipmentBeijing Globalipl Development Co., Ltd.20220—
+8K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+8K220853PicoWay Laser SystemCandela Corporation20221—
+8K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+8K222265DiosculptShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20220—
+8K211681EONDominion Aesthetic Technologies, Inc.20221—
+8K212478Dermatological diode laser systemBeijing Stelle Laser Technology Co., Ltd.20220—
+8K212127PicocaremajestyWontech Co., Ltd.20226—
+8K213225Diode Laser System GP900A8, Diode Laser System GP900Q8Shenzhen Gsd Tech Co., Ltd.20210—
+8K212331BodySculpRohrer Aesthetics, LLC20211—
+8K201773PicohiHironic Co., Ltd.20215—
+8K211402Powersculp laser lipolysis systemLotuxs Medtech (Suzhou) Co., Ltd.20210—
+8K211335Diode Laser Machine, Model Number: BM-100Zhengzhou Bestview ST Co., Ltd.20215—
+8K211821DEKA Motus AZEl.En Electronic Engineering Spa20211—
+8K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+8K202257Dermatological Diode Laser SystemsZhuolu Jontelaser Manufacturing Technology Co., Ltd.20210—
+8K203491PicoLO Nd: YAG Picosecond Laser SystemLaseroptek Co., Ltd.20211—
+8K201387Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc.20210—
+8K202980Laser Therapy DeviceShenzhen Leaflife Technology Co., Ltd.20202—
+8K201731Diode Laser Body Sculpture SystemShanghai Apolo Medical Technology Co., Ltd.20201—
+8K200786Venus EpileveVenus Concept USA, Inc.20200—
+8K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—
+8K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+8K191970Diode Laser Hair Removal SystemBeijing Sano Laser S&T Development Co.,Ltd20200—
+8K193328IPL + Diode Laser MachineBeijing Globalipl Development Co., Ltd.20200—
+8K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+8K191855EmFace DeviceInmode MD, Ltd.20191—
+8K192425Hair Boom 69, Hair Boom Air, Ulike Hair UpUpWontech Co., Ltd.20192—
+8K190743Venus BlissVenus Concept USA, Inc.20194—
+8K182924Diode Laser Treatment SystemWeifang KM Electronics Co., Ltd.20192—
+8K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+8K182604New EraStep UP Skin Laser, LLC201801
+8K181095RF-ReliefEl Global Trade, Ltd.20181—
+8K180353Diode laser hair removal deviceZhengzhou PZ Laser Slim Technology Co., Ltd.201824—
+8K180406Ellipse YdunEllipse A/S20180—
+8K173677InMode VLazeInmode MD, Ltd.20183—
+8K172302InMode PLUS SystemInmode MD, Ltd.201713—
+8K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+8K171111SculpsureCynosure, Inc.201710—
+8K163222Discovery Pico FamilyQuanta System Spa201630—