510(k) Report

Devices descending from K001179

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+6K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+6K260129Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )Shenzhen Kaiyan Medical Equipment Co., Ltd.20261—
+6K253833Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004…Shenzhen Jianchao Intelligent 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—
+6K252187Aura Glide (FC40)Aura Medical, LLC20250—
+6K252994LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7…Guangdong Ace-Tec Co., Ltd.20250—
+6K251825Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)Shenzhen Ulike Smart Electronics Co., Ltd.20250—
+6K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+6K242859VEGAIbramed Equipamentos Médicos20250—
+6K251781Kala Mini 2.0 (Kala-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+6K251667LED Light Therapy Mask (M01, M02, M06, M07, M08, M09)Shenzhen Liyoutong Technology Co., Ltd.20250—
+6K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+6K251017CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+6K251042Light Therapy System (M500, L6)Guangzhou Ahead Intelligent Technology Co., Ltd.20251—
+6K250467Red Light Hair Growth Cap (LP-RJVGRW-BLK)Shenzhen Idea Light Limited20250—
+6K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+6K241947EnergyLounger (TY-01)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+6K242593CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)Shenzhen Kaiyan Medical Equipment Co., Ltd.20253—
+6K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+6K243393JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30U MP)Shenzhen Ulike Smart Electronics Co., Ltd.20251—
+6K243492Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20253—
+6K242789Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006)Dongguan Laiguang Electronic Technology Co., Ltd.20253—
+6K243430Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)Shenzhen Aozemei Technology Co., Ltd.20243—
+6K242700Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A…Shenzhen Nuon Medical Equipment Co., Ltd.20246—
+6K241342Hair Growth Comb (SZ-23,SZ-23A)Shenzhen Nuon Medical Equipment Co., Ltd.20240—
+6K241718Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)Shenzhen Aozemei Technology Co., Ltd.202412—
+6K241656Eneka SelectifTermosalud20241—
+6K241203PMD Clean Redvolution (4005-moab-NA, 4005-moab-INT, 4005-pepper-NA, 4005-pepper-INT…Dongguan Hunter Electronic Technology Co., Ltd.20240—
+6K241293LED Light Therapy Device, ELIXIR MD™Yassen Wellness, LLC20247—
+6K241600DermablateAsclepion Laser Technologies GmbH20240—
+6K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+6K233473Deka LotusEl.En S.P.A.20241—
+6K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+6K233926accufitMettler Electronics Corporation20244—
+6K233077FlashHeal 2 (FlashHeal 2.0)Inwound Aps20240—
+6K232863Radiant Renewal Skincare Wand (HD-15, HD-15A)Shenzhen Kaiyan Medical Equipment Co., Ltd.20230—
+6K232356Laser Cap, Model: Hat-01Hubei Yjt Technology Co.,Ltd20230—
+6K232236EchoQuanta System Spa20230—
+6K231894LED Spectrum therapy instrumentShenzhenshi Sincoheren S&T Development Co., Ltd.20230—
+6K231054V-LaserWontech Co., Ltd.20231—
+6K231321Nooance Led And Laser HelmetShenzhen Kaiyan Medical Equipment Co., Ltd.20231—
+6K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+6K230293TheraFace MaskTherabody, Inc.202316—
+6K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+6K230597Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B)Light Tree Ventures Europe B.V.20232—
+6K223544LED light therapy mask (FM-01, FM-02, FM-03)Guangdong Newdermo Biotech Co., Ltd.202339—
+6K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+6K223540AvalancheLase FamilyFotona D.O.O.20230—
+6K213267Dynamis Pro FamilyFotona D.O.O.20222—
+6K220064Synergy Marble (Model: Opasm)Yrs Group, Inc.20220—
+6K221571InMode Multi-systemInMode, Ltd.20222—
+6K210545Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty…Marci Beauty, Inc.20222—
+6K213350mJOULE System and AccessoriesSciton, Inc20220—
+6K212155TheraFace LEDTheragun, Inc.202142—
+6K212275Dermalux Flex MDAesthetic Technology, Ltd.20214—
+6K212238TheraFace MicrocurrentTheragun, Inc.20210—
+6K202390Aduro Light Beauty MaskShenzhen Kaiyan Medical CO, Ltd.202139—
+6K203788DermaV Laser SystemLutronic Corporation202101
+6K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+6K193266MIINMedico USA, Inc.20210—
+6K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+6K202172StarWalkerFotona D.O.O.20203—
+6K201406PicowonWontech Co., Ltd.20200—
+6K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+6K200736Stardust MedI.T.S. Group S.R.L.20200—
+6K200929Hair Growth SystemXuzhou Kernel Medical Equipment Co., Ltd.20200—
+6K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+6K192552Irradiation Cosmetic DeviceChongqing Peninsula Medical Technology Co., Ltd.20202—
+6K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+6K190467iHelmet Hair Growth SystemSlinph Technologies Co., Ltd.20196—
+6K192430Epic 980Biolase, Inc.20195—
+6K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+6K183156V-LaserWontech Co., Ltd.20193—
+6K182562Hair Boom 69Wontech20184—
+6K181518Sebacia MicroparticlesSebacia, Inc.20180—
+6K181019Diode Laser SystemGuangzhou Huafei Tongda Technology Co., Ltd.20186—
+6K180967Dental Diode Laser SystemLazon Medical Laser Co., Ltd.20180—
+6K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+6K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+6K173199PicoSure WorkstationCynosure, Inc.20189—
+6K171835Irradiation Aesthetic DeviceChongqing Peninsula Medical Technology Co., Ltd.20185—
+6K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+6K162755PicocareWontech Co., Ltd.20179—
+6K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+6K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+6K170500SIROLaser Advance+Dentsply Sirona201721—
+6K162782iHelmet Hair Growth SystemSlinph Technologies Co., Ltd.201722—
+6K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+6K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.20163—
+6K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+6K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+6K152856Helios IIILaseroptek Co., Ltd.20165—
+6K160480PicoSure WorkstationCynosure, Inc.201620—
+6K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+6K152611V20 systemViora, Ltd.20164—
+6K153718Spirit Hair Removal laser FamilyActive Optical Systems, Ltd.20167—
+6K152898Diode Laser Therapy SystemsBeijing Sincoheren Science and Tech. Development Co., Ltd.20161—
+6K150724SculpSureCynosure, Inc.201521—
+6K150230SculpSureCynosure, Inc.201521—