510(k) Report

Devices descending from K001179

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K150035V10 systemViora, Ltd.201531—
+6K150326PicoWay Laser SystemCandela Corporation201568—
+6K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa201516—
+6K143105Picosure WorkstationCynosure, Inc.201549—
+6K141986Elux 810 LaserEquipmed North America, Inc.20150—
+6K142372Pico Way Laser SystemCandela Corpation201470—
+6K141564Opton ProZimmer Medizinsystems GmbH20140—
+6K142376Palomar Icon Aesthetic SystemCynosure, Inc.201413—
+6K140719Picosure WorkstationCynosure, Inc.201450—
+6K131838Diode Laser for Hiar RemovalBeijing Honkon Technologies Co., Ltd.20140—
+6K130028Resurfx 1565NM Laser ModuleLumenis, Ltd.201341—
+6K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+6K123483Diode LaserBeijing Syntech Laser CO., LTD.201353—
+6K120622Palomar Vectus LaserPalomar Medical Technologies, Inc.20124—
+6K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+6K103511Litecure Therapy SystemLitecure, LLC20110—
+7K260945Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension…Fit-Pro KFT (Ltd.) - DBA E-Fit20260—
+7K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+7K252723Dynamis Pro FamilyFotona D.O.O.20260—
+7K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.20260—
+7K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+7K260767Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty…Kam Yuen Plastic Products, Ltd.20260—
+7K260899Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157…Zdeer Technology (Henan) Co., Ltd.20260—
+7K260715CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd.20260—
+7K260895Ulike Clear Zero (YC10 BU)Guangxi Ulike Medical Technology Co., Ltd.20260—
+7K260511Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20260—
+7K253874LED Therapy Light (COB1400, HP1800PRO)Shenzhen Hanhua Opto Co., Ltd.20260—
+7K252603HIGHERDOSE Body Sculptor (Model: GS-03)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+7K253342PICO-KSpeclipse, Inc.20251—
+7K253400LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X…Shenzhen Saidi Light Therapy Technology Co., Ltd.20250—
+7K252146Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003…Shenzhen Siken 3D Technology Development Co., Ltd.20251—
+7K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+7K253054LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.20250—
+7K252142Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909…Shenzhen Siken 3D Technology Development Co., Ltd.20250—
+7K253344Bellus-QSpeclipse, Inc.20250—
+7K253073LED Light Therapy Device (SG-FSM, SG-NK, SG-CT)Sunglor Technology Co., Ltd.20251—
+7K252642Microcurrent Facial Device (CEC101, EEI101)Shenzhen Dachi Communication Co., Ltd.20250—
+7K252053VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343F, TB-2442F)Touchbeauty Beauty & Health ( Shenzhen ) Co., Ltd20250—
+7K252272ORA Method LED Gua Sha (GS-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+7K252189LED Light Therapy Mask (2311, 2344, 2457, 2458)Dongguan Yanxi Technology Co., Ltd.20250—
+7K251727GLAM LED Facial Mask (TB-2386F)Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.20250—
+7K251594truFlexSyrma Johari Medtech Limited20250—
+7K251588LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910)Shenzhen Fittop Health Technology Co., Ltd.20252—
+7K251012TRUDERMAL Pro (ZLD-390)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+7K251076Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)Shenzhen Lifotronic Technology Co., Ltd.20250—
+7K250761KALA Therapy Wand (Model: KALA-03)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+7K251632Optimas MAX SystemInMode, Ltd.20251—
+7K243978LED Facial MaskShenzhen Sunsred Technology Co.,Ltd20250—
+7K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+7K251094Alma VeilWontech Co., Ltd.20250—
+7K250308Hair Growth Device (KCA441-200, KCA441-120, KCA441-88, KCA441-56, KCA441-200S…Dongguan Boyuan Intelligent Technology Co.,Ltd20251—
+7K242151Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B)Shenzhen Nuon Medical Equipment Co., Ltd.20251—
+7K242385LED Therapy Mask (MN1, M226)Shenzhen Borria Technology Co., Ltd.20253—
+7K250281Deka LotusEl.En S.P.A.20250—
+7K243555LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A)Shenzhen Eyco Technology Co., Ltd.20250—
+7K241270BTL-754BTL Industries, Inc.20251—
+7K243423LED Light Therapy Mask (Model (s): RB-008, RB-030, RB-081, RB-008G, RB-008GB, RB-008J…Shenzhen Rainbow Technology Co., Ltd.20253—
+7K242638LED Light Therapy Machine (G1, G3, G4, G6)Shenzhen Walton Technology Co., Ltd.20241—
+7K242796CryoGlow (FW3XXXX)Sharkninja Operating, LLC20244—
+7K241857LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)Dongguan Boyuan Intelligent Technology Co.,Ltd202421—
+7K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+7K242206ActivoDaeju Meditech Engineering Co., Ltd.20240—
+7K241933HIGHERDOSE Red and Infrared Light Mask (MK66-L)Shenzhen Kaiyan Medical Equipment Co., Ltd.20241—
+7K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+7K241102Luna 4 plusForeo, Inc.20245—
+7K241685SofWave SystemSofwave Medical, Ltd.20242—
+7K233757TitanPico Laser Workstation (PICO-450)Rhein Laser Technologies Co., Ltd.20240—
+7K240360Wrinkle Treatment Device (JM2)Shenzhen Qianyu Technology Co., Ltd.20242—
+7K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+7K232222Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)Medency S.R.L.20230—
+7K233090DEKA AGAIN PRO familyEl.En S.P.A.20232—
+7K223919B.Light Clear Evo and B.Light Restore EvoBemer Int AG20232—
+7K230077LaserMENeauvia North America20232—
+7K221427V-LaserWontech Co., Ltd.20222—
+7K212663Helios IV 785Laseroptek Co., Ltd.20223—
+7K220168Skin Care Beauty Mask (Model: MJ-06)Shenzhen Kaiyan Medical CO, Ltd.202234—
+7K210367D-Laser Blue, D-Laser 16Guilin Woodpecker Medical Instrument Co., Ltd.20226—
+7K202848S2 Pigment Removal SystemLightsense Technologies, Ltd.20210—
+7K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+7K210226PicoSure WorkstationCynosure, LLC20213—
+7K200693K2 MobileHulaser, Inc.20202—
+7K200525Medical Diode Laser Hair Removal SystemWeifang Mingliang Electronics Co., Ltd.20201—
+7K193486Epic 980Biolase, Inc.20202—
+7K193426Elite iQCynosure, LLC20201—
+7K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—
+7K192627Laser Hair Growth CapShang FA Biotechnology Co.20191—
+7K192569Diode Laser Therapy SystemSan HE Lefis Electronics Co., Ltd.20191—
+7K192516Diode Laser 808nmBeijing Superlaser Technology Co., Ltd.20191—
+7K191685PicoWay Laser SystemCandela Corporation201920—
+7K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+7K191154Hair Boom 69Wontech20193—
+7K191068Powersculp laser lipolysis systemWuhan Lotuxs Technology Co., Ltd.20196—
+7K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+7K183392PicoLO Nd:YAG Picosecond Laser SystemLaseroptek Co., Ltd.20192—
+7K182997enlighten III Laser SystemCutera, Inc.20180—
+7K181486DEKA Motus AYEl.En Electronic Engineering Spa20182—
+7K181272Picocare FamilyWontech Co., Ltd.20188—
+7K173700PICOPLUS Laser SystemLutronic Corporation20187—
+7K180044SIROLaser BlueDentsply Sirona201812—
+7K170060M22 and ResurFx SystemsLumenis, Ltd.201724—