510(k) Report

Devices descending from K001179

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+8K153566Magma SystemFormatk Systems, Ltd.20162—
+9K262070Diode Laser Therapy Systems (DL612A)Hebei Zollvan Medical Technology Co., Ltd.20260—
+9K261851LED Light Therapy Mask (JML1, JML1+JML2); LED Light Therapy Mask (JML3, JML3+JML4); LED…Shenzhen Qianyu Technology Co., Ltd.20260—
+9K261407XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342, XPRE368, XPRE422…Dongguan Miqiang Technology Co., Ltd.20260—
+9K260138LUNE PureHygieneEnamel Pure20260—
+9K260017Picosecond Nd:YAG Laser Systems (Model: HS-298)Shanghai Apolo Medical Technology Co., Ltd.20260—
+9K253829Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+9K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+9K252753Vydence Family of LasersVydence Medical Industria E Commercio Ltda20260—
+9K253135LED Light Therapy Device (HLGMZ-3W-G1V1,HLGMZ-3W-G2V1,HLG-GJXJ-G1V1,HGMZ-2W-G1V1…Dongguan Yijiaming Technology Co., Ltd.20250—
+9K252427Diode Laser Hair Removal Machine (GLD01)Sanhe Meditech Co., Ltd.20250—
+9K252447Picosecond laser device (BMPS4)Hebei Newangie Technology Co., Ltd.20250—
+9K250734OptiLUV DevicePollogen, Ltd.20250—
+9K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—
+9K251746Pure ImpactSofwave Medical, Ltd.20250—
+9K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+9K242755Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE…Gigaalaser Company, Ltd.20251—
+9K250041Medical Picosecond ND: YAG Laser System (PZ-6)Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+9K242951Diode laser hair removal machine (QDTM-02)Beijing Nubway S&T Co., Ltd.20251—
+9K250809Stellar M22Lumenis Be, Ltd.20250—
+9K243139Reverso Pro SystemIndiba S. A. U.20250—
+9K243040LED Light Therapy Mask…Shenzhen Siken 3D Technology Development Co., Ltd.20241—
+9K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+9K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+9K241547Diode Laser Therapy Device (DF-DIODE LASER-S1)Weifang Dragonfly Electronics Technology Co., Ltd.20240—
+9K241642Diode Laser Hair Removal System (MBT-Diode Laser)Beijing Mega Beauty Technology Co., Ltd.20240—
+9K241144Picosecond Nd:YAG Laser (PICOCAREMAJESTY)Wontech Co., Ltd.20241—
+9K241459MOTUS PRO FamilyEl.En S.P.A.20240—
+9K233007Picosecond Nd:YAG Laser System; PICO LEGENDAmi, Inc.20241—
+9K233099GladiatorRohrer Aesthetics, LLC20240—
+9K240752Deka ToroEl.En S.P.A.20240—
+9K2406581060nm laser body slimming machineHebei JT Medical Co., Ltd.20240—
+9K240118Picosecond Nd:YAG Laser SystemSmedtrum Medical Technology Co., Ltd.20240—
+9K233962ReBorn (1050nm)Lightfective, Ltd.20240—
+9K234104PICOANDY (Q-Switched Nd:YAG Laser)Wontech Co., Ltd.20242—
+9K233018PICOSECOND Nd:YAG Laser SystemIds, Ltd.20232—
+9K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+9K222790F65 Laser SystemLumenis Be, Ltd.20233—
+9K223862Hair Boom 69, Hair BoomAir, Hair Boom, Ulike Hair UpUpWontech Co., Ltd.20231—
+9K222226EONDominion Aesthetic Technologies, Inc.20230—
+9K222221Deka HelixEl.En Electronic Engineering Spa20231—
+9K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+9K220268Picosecond Laser System (Model PS10-A and PS10-B)Beijing Adss Development Co., Ltd.20221—
+9K220381Diode Laser Therapy SystemsBeijing Lasertell Medical Co., Ltd.20221—
+9K220103LED Therapy Device (Planar LED/Planar LED mini)Shenzhen Leaflife Technology Co., Ltd.20221—
+9K213308Venus BlissMAXVenus Concept USA, Inc.20222—
+9K212573PicoLO PremiumLaseroptek Co., Ltd.20210—
+9K210168Diode Laser Therapy SystemsBeijing Kes Biology Technology Co., Ltd.20214—
+9K210663Dermatological Diode Laser SystemsBeijing HuaCheng Taike Technology Co., Ltd.20218—
+9K210033Laser Treatment System, Model: NYX and GraceCanadian Pioneer Medical Technology Corporation20211—
+9K192970SlimusHironic Co., Ltd.20200—
+9K192735Diode Laser Hair Removal MachineBeijing Lead Beauty S & T Co., Ltd.20202—
+9K183450EmBody SystemInmode MD, Ltd.20198—
+9K171992SculpSureCynosure, Inc.20178—
+9K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+9K162781Magma SparkFormatk Systems, Ltd.20160—
+10K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+10K261693Diode laser hair removal machine (QDTM-04)Beijing Nubway S&T Co., Ltd.20260—
+10K253965CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight…Wuhan PHOMED Technology Company, Ltd.20260—
+10K251457Diode laser therapy device (VADER)Beijing Superlaser Technology Co., Ltd.20250—
+10K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+10K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.20251—
+10K240991eMVFit (MVF-10M)Weero Co., Ltd.20240—
+10K242349FoLixLumenis Be, Ltd.20240—
+10K240064Hair Boom Air / Ulike Hair UpUp / Hair Boom 69 / Hair BoomWontech Co., Ltd.20240—
+10K232709Diode laser therapy deviceHebei Zhemai Technology Co., Ltd.20231—
+10K231901Hakon, Hakon SmartMedical San Indústria DE Equipamentos Médicos Ltda.20230—
+10K231971Deka Physiq 360El.En S.P.A.20230—
+10K230362Planar LED mateShenzhen Leaflife Technology Co., Ltd.20230—
+10K221312Diode Laser Hair Removal DeviceGuangzhou Chuang Zao Mei Technology Co., Ltd.20224—
+10K220592Venus BlissMAXVenus Concept USA, Inc.20221—
+10K212978Diode laser therapy systemBeijing Unt Technology Co., Ltd.20211—
+10K212793Laser Treatment System, Model: Hera, ArmoCanadian Pioneer Medical Technology Corporation20210—
+10K210877Evolve System with the T3 ApplicatorInMode, Ltd.20215—
+10K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd.20216—
+10K182741SculpSureCynosure20195—
+10K172376Discovery Pico, Discovery Pico PlusQuanta System Spa201720—
+11K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+11K260307Diode Laser Therapy Systems (V19)Weifang Mingliang Electronics Co., Ltd.20260—
+11K252845Venus Nova (FP-2001)Venus Concept, Inc.20250—
+11K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.20250—
+11K251801Diode laser device (BM091)Hebei Newangie Technology Co., Ltd.20250—
+11K241433EVE Synergy (EVE-20M)Weero Co., Ltd.20251—
+11K250431Medical Diode Laser Hair Removal System (MNLT-D1)Shandong Moonlight Electronics Tech Co., Ltd.20251—
+11K243465Diode Laser Hair Removal Device (EVOLUTION MEDICAL); Diode Laser Hair Removal Device…Guangzhou Chuang Zao Mei Technology Co., Ltd.20250—
+11K241498Diode laser Treatment System (K18)Hebei Keylaser Sci-Tech Co.,Ltd20240—
+11K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+11K230167BACK 4Swims America Corp20230—
+11K230037BACK 3Swims America Corp20230—
+11K231131Diode Laser Body Sculpture SystemsShanghai Bele Medical Technology Co.,Ltd20230—
+11K213889PicoStarAsclepion Laser Technologies GmbH20220—
+11K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa201918—
+12K252048808nm semiconductor laser hair removal machineXi'An Taibo Electronic Technology Co., Ltd.20260—
+12K202503ChromeQuanta System Spa202012—
+13K253765Vanish ProDdc Technologies, Inc.20260—
+13K241527Pastelle ProWontech Co., Ltd.20253—
+13K223404Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4VQuanta System Spa20230—
+13K213726PL-1 Skin Treatment SystemAVAVA, Inc.20220—
+13K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—