510(k) Report

Devices descending from K950239

1,329 later devices reach Sensimatic 500SE through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K152417Adler MicroMed Laser Surgery FibersAdler Micromed, Inc.20153—
+11K151179ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201526—
+11K150724SculpSureCynosure, Inc.201521—
+11K150230SculpSureCynosure, Inc.201521—
+11K143741Lipofina Laser SystemYolo Medical, Inc.20153—
+11K150326PicoWay Laser SystemCandela Corporation201568—
+11K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa201516—
+11K143105Picosure WorkstationCynosure, Inc.201549—
+11K142491ZEL TIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201527—
+11K142372Pico Way Laser SystemCandela Corpation201470—
+11K140719Picosure WorkstationCynosure, Inc.201450—
+11K133212Zeltiq Coolsculpting SystemZeltiq Aesthetics, Inc.201430—
+11K133563Pathassist Light SeekerEntellus Medical, Inc.20130—
+11K132440Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201314—
+11K130341Strawberry, Strawberry & CreamLaser Lipo Limited201312—
+12K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+12K261370LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))Guangdong Newdermo Biotech Co., Ltd.20260—
+12K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+12K261496LED Light Therapy Masks (PE748, PE749, PE756)Duplex International Trading Limited20260—
+12K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+12K260895Ulike Clear Zero (YC10 BU)Guangxi Ulike Medical Technology Co., Ltd.20260—
+12K260150Led Facial Mask (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C)Nooance20260—
+12K260765Gemini NOVA 810+980 Soft Tissue LaserAzena Medical, LLC20260—
+12K252603HIGHERDOSE Body Sculptor (Model: GS-03)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+12K253712LED 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—
+12K253400LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X…Shenzhen Saidi Light Therapy Technology Co., Ltd.20250—
+12K253135LED Light Therapy Device (HLGMZ-3W-G1V1,HLGMZ-3W-G2V1,HLG-GJXJ-G1V1,HGMZ-2W-G1V1…Dongguan Yijiaming Technology Co., Ltd.20250—
+12K252983Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03)Shenzhen Goodwind Technology Development Co., Ltd.20250—
+12K252142Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909…Shenzhen Siken 3D Technology Development Co., Ltd.20250—
+12K253073LED Light Therapy Device (SG-FSM, SG-NK, SG-CT)Sunglor Technology Co., Ltd.20251—
+12K252642Microcurrent Facial Device (CEC101, EEI101)Shenzhen Dachi Communication Co., Ltd.20250—
+12K252053VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343F, TB-2442F)Touchbeauty Beauty & Health ( Shenzhen ) Co., Ltd20250—
+12K250731MateLaser Medical Diode Laser Systems (ML-DLS-30)Matelaser, Inc.20250—
+12K252189LED Light Therapy Mask (2311, 2344, 2457, 2458)Dongguan Yanxi Technology Co., Ltd.20250—
+12K250734OptiLUV DevicePollogen, Ltd.20250—
+12K250217AGNES UltraAgnes Medical Co., Ltd.20250—
+12K243713Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A…Agnes Medical Co., Ltd.20250—
+12K251871FEATHER 01 02 03 04 (Model:01)Heat IN A Click, LLC20250—
+12K251012TRUDERMAL Pro (ZLD-390)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+12K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+12K243978LED Facial MaskShenzhen Sunsred Technology Co.,Ltd20250—
+12K250880Led Light Mask (A093)Foshan Guangyu Weilai Medical Equipment Co., Ltd.20250—
+12K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+12K241433EVE Synergy (EVE-20M)Weero Co., Ltd.20251—
+12K243764Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)Wuhan Pioon Technology Co., Ltd.20250—
+12K244020Wrinkle Treatment Device (JM1, JM2B)Shenzhen Qianyu Technology Co., Ltd.20250—
+12K242385LED Therapy Mask (MN1, M226)Shenzhen Borria Technology Co., Ltd.20253—
+12K243587PureLift GLOWXtreem Pulse, LLC20251—
+12K250281Deka LotusEl.En S.P.A.20250—
+12K243330LYMA Laser PROLyma Life, Ltd.20250—
+12K241643WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)Wontech Co., Ltd.20252—
+12K243147LGO-Surgical Laser FibersLight Guide Optics International, Ltd.20241—
+12K241670Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System…Beijing Adss Development Co., Ltd.20241—
+12K242638LED Light Therapy Machine (G1, G3, G4, G6)Shenzhen Walton Technology Co., Ltd.20241—
+12K242796CryoGlow (FW3XXXX)Sharkninja Operating, LLC20244—
+12K242553MIRARI® Cold Plasma System ( GV-M2-01)General Vibronics, Inc.20240—
+12K241857LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)Dongguan Boyuan Intelligent Technology Co.,Ltd202421—
+12K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+12K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+12K242206ActivoDaeju Meditech Engineering Co., Ltd.20240—
+12K241933HIGHERDOSE Red and Infrared Light Mask (MK66-L)Shenzhen Kaiyan Medical Equipment Co., Ltd.20241—
+12K242349FoLixLumenis Be, Ltd.20240—
+12K240780InMode RF SystemInMode, Ltd.20243—
+12K233757TitanPico Laser Workstation (PICO-450)Rhein Laser Technologies Co., Ltd.20240—
+12K234085LUNE™ PureHygieneEnamel Pure20241—
+12K230047Medical Diode Laser SystemsGigaalaser Company, Ltd.20242—
+12K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+12K233556LED Eye mask (EY-20R, A20, EY-20N)Shenzhen Kaiyan Medical Equipment Co., Ltd.20241—
+12K232795Led Mask Platinum Exclusive MDStg24 Co., Ltd.20230—
+12K232769BeaMed Laser Surgery FibersBt Beamedical Tachnoogies Ltd. (Beamed)20231—
+12K233090DEKA AGAIN PRO familyEl.En S.P.A.20232—
+12K230167BACK 4Swims America Corp20230—
+12K230037BACK 3Swims America Corp20230—
+12K220322Pollogen STOP U Model UXV DevicePollogen, Ltd.20233—
+12K230819OmniGuide RFID Surgical Laser FibersOmni-Guide Holdings, Inc.20230—
+12K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+12K223110truSculpt iDCutera, Inc.20221—
+12K212663Helios IV 785Laseroptek Co., Ltd.20223—
+12K220793InnoVoyce Laser FiberInnovoyce, LLC20220—
+12K220168Skin Care Beauty Mask (Model: MJ-06)Shenzhen Kaiyan Medical CO, Ltd.202234—
+12K212891TempSure SystemCynosure, LLC20221—
+12K202848S2 Pigment Removal SystemLightsense Technologies, Ltd.20210—
+12K212814C2 CryoBalloon Ablation SystemPentax of America, Inc.20211—
+12K210129RF Thermal SystemLuvo Medical Technologies, Inc.20211—
+12K211107BTL-899 FPBTL Industries, Inc.20213—
+12K210948Omnilux CLEARGlobalmed Technologies202139—
+12K210226PicoSure WorkstationCynosure, LLC20213—
+12K201387Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc.20210—
+12K193426Elite iQCynosure, LLC20201—
+12K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—
+12K191685PicoWay Laser SystemCandela Corporation201920—
+12K191629faceLITEIsmart Marketing Svcs, Ltd.201971—
+12K191068Powersculp laser lipolysis systemWuhan Lotuxs Technology Co., Ltd.20196—
+12K183671LG Pra.L Derma Led MaskLg Electronics.Inc201948—
+12K183392PicoLO Nd:YAG Picosecond Laser SystemLaseroptek Co., Ltd.20192—
+12K182997enlighten III Laser SystemCutera, Inc.20180—
+12K181486DEKA Motus AYEl.En Electronic Engineering Spa20182—
+12K181272Picocare FamilyWontech Co., Ltd.20188—
+12K173700PICOPLUS Laser SystemLutronic Corporation20187—
+12K180406Ellipse YdunEllipse A/S20180—