510(k) Report

Devices descending from K964143

978 later devices reach Mini-Symm Bipolar Coagulator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K253480Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L.20260—
+10K260895Ulike Clear Zero (YC10 BU)Guangxi Ulike Medical Technology Co., Ltd.20260—
+10K260150Led Facial Mask (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C)Nooance20260—
+10K253750BTL-785NEHBTL Industries, Inc.20260—
+10K260765Gemini NOVA 810+980 Soft Tissue LaserAzena Medical, LLC20260—
+10K252603HIGHERDOSE Body Sculptor (Model: GS-03)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+10K253712LED 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—
+10K253400LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X…Shenzhen Saidi Light Therapy Technology Co., Ltd.20250—
+10K253135LED Light Therapy Device (HLGMZ-3W-G1V1,HLGMZ-3W-G2V1,HLG-GJXJ-G1V1,HGMZ-2W-G1V1…Dongguan Yijiaming Technology Co., Ltd.20250—
+10K252983Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03)Shenzhen Goodwind Technology Development Co., Ltd.20250—
+10K252142Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909…Shenzhen Siken 3D Technology Development Co., Ltd.20250—
+10K253073LED Light Therapy Device (SG-FSM, SG-NK, SG-CT)Sunglor Technology Co., Ltd.20251—
+10K252642Microcurrent Facial Device (CEC101, EEI101)Shenzhen Dachi Communication Co., Ltd.20250—
+10K252845Venus Nova (FP-2001)Venus Concept, Inc.20250—
+10K252053VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343F, TB-2442F)Touchbeauty Beauty & Health ( Shenzhen ) Co., Ltd20250—
+10K250731MateLaser Medical Diode Laser Systems (ML-DLS-30)Matelaser, Inc.20250—
+10K252189LED Light Therapy Mask (2311, 2344, 2457, 2458)Dongguan Yanxi Technology Co., Ltd.20250—
+10K251871FEATHER 01 02 03 04 (Model:01)Heat IN A Click, LLC20250—
+10K251012TRUDERMAL Pro (ZLD-390)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+10K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+10K250065DENSITY; DENZA; DENSITY NoirJeisys Medical Incorporated20250—
+10K243978LED Facial MaskShenzhen Sunsred Technology Co.,Ltd20250—
+10K250880Led Light Mask (A093)Foshan Guangyu Weilai Medical Equipment Co., Ltd.20250—
+10K250782Fractional CO2 Laser MachineZhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+10K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+10K243764Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)Wuhan Pioon Technology Co., Ltd.20250—
+10K244020Wrinkle Treatment Device (JM1, JM2B)Shenzhen Qianyu Technology Co., Ltd.20250—
+10K242385LED Therapy Mask (MN1, M226)Shenzhen Borria Technology Co., Ltd.20253—
+10K243587PureLift GLOWXtreem Pulse, LLC20251—
+10K243330LYMA Laser PROLyma Life, Ltd.20250—
+10K241643WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)Wontech Co., Ltd.20252—
+10K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+10K243139Reverso Pro SystemIndiba S. A. U.20250—
+10K243147LGO-Surgical Laser FibersLight Guide Optics International, Ltd.20241—
+10K241670Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System…Beijing Adss Development Co., Ltd.20241—
+10K242532BTL-785BNF-EBTL Industries, Inc.20241—
+10K242638LED Light Therapy Machine (G1, G3, G4, G6)Shenzhen Walton Technology Co., Ltd.20241—
+10K242796CryoGlow (FW3XXXX)Sharkninja Operating, LLC20244—
+10K240897CellinewVIOL Co., Ltd.20240—
+10K242183Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd.20240—
+10K241857LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)Dongguan Boyuan Intelligent Technology Co.,Ltd202421—
+10K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+10K242206ActivoDaeju Meditech Engineering Co., Ltd.20240—
+10K241933HIGHERDOSE Red and Infrared Light Mask (MK66-L)Shenzhen Kaiyan Medical Equipment Co., Ltd.20241—
+10K233473Deka LotusEl.En S.P.A.20241—
+10K222958mJOULE RF System and AccessoriesSciton, Inc20240—
+10K233757TitanPico Laser Workstation (PICO-450)Rhein Laser Technologies Co., Ltd.20240—
+10K234085LUNE™ PureHygieneEnamel Pure20241—
+10K230047Medical Diode Laser SystemsGigaalaser Company, Ltd.20242—
+10K240313Oligio XWontech Co., Ltd.20241—
+10K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+10K233556LED Eye mask (EY-20R, A20, EY-20N)Shenzhen Kaiyan Medical Equipment Co., Ltd.20241—
+10K232795Led Mask Platinum Exclusive MDStg24 Co., Ltd.20230—
+10K232769BeaMed Laser Surgery FibersBt Beamedical Tachnoogies Ltd. (Beamed)20231—
+10K233090DEKA AGAIN PRO familyEl.En S.P.A.20232—
+10K231495The Evolve System with the Transform ApplicatorInMode, Ltd.20231—
+10K231092T-Shape 2B&M S.R.L. Marketing Nel Benessere20230—
+10K232192Venus Versa PRO SystemVenus Concept, Inc.20230—
+10K230819OmniGuide RFID Surgical Laser FibersOmni-Guide Holdings, Inc.20230—
+10K221574LUDWIG Electrosurgical DeviceAesthetics Biomedical20220—
+10K213120OW100S (model OW100S-US)Tissue Regeneration Technologies, LLC Dba AS Softwave Trt20220—
+10K212663Helios IV 785Laseroptek Co., Ltd.20223—
+10K210084SilkroHironic Co., Ltd.20223—
+10K220793InnoVoyce Laser FiberInnovoyce, LLC20220—
+10K220168Skin Care Beauty Mask (Model: MJ-06)Shenzhen Kaiyan Medical CO, Ltd.202234—
+10K220592Venus BlissMAXVenus Concept USA, Inc.20221—
+10K220124YandR System, VoluDerm Handpiece, VoluDerm TipsPollogen, Ltd.20220—
+10K202848S2 Pigment Removal SystemLightsense Technologies, Ltd.20210—
+10K212107ReversoIntelis Instruments, Ltd.20211—
+10K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+10K210948Omnilux CLEARGlobalmed Technologies202139—
+10K210226PicoSure WorkstationCynosure, LLC20213—
+10K201387Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc.20210—
+10K203665STOP U Model UXV DevicePollogen, Ltd.20214—
+10K201685PotenzaJeisys Medical, Inc.20219—
+10K201735PlaDuo SystemShenB Co., Ltd.20203—
+10K200947InMode System with the Morhpeus8 ApplicatorsInMode, Ltd.202015—
+10K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+10K193426Elite iQCynosure, LLC20201—
+10K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—
+10K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+10K192224BTL-899Btl20198—
+10K191685PicoWay Laser SystemCandela Corporation201920—
+10K191629faceLITEIsmart Marketing Svcs, Ltd.201971—
+10K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+10K183671LG Pra.L Derma Led MaskLg Electronics.Inc201948—
+10K183392PicoLO Nd:YAG Picosecond Laser SystemLaseroptek Co., Ltd.20192—
+10K182997enlighten III Laser SystemCutera, Inc.20180—
+10K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+10K181486DEKA Motus AYEl.En Electronic Engineering Spa20182—
+10K181272Picocare FamilyWontech Co., Ltd.20188—
+10K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+10K173700PICOPLUS Laser SystemLutronic Corporation20187—
+10K180709truSculpt RF Device; truSculpt; truSculpt 3DCutera, Inc.20183—
+10K173582ThermiX Temperature Control Radiofrequency System, Accessories - RF ElectrodesThermigen, L.L.C20181—
+10K171262TempSureCynosure, Inc.201716—
+10K172004truSculptCutera, Inc.20173—
+10K170637sensiFirmEl Global Trade, Ltd.20173—
+10K162886Deka Motus AXEl.En Electronic Engineering Spa20171—
+10K171094Thermi Reusable Non-invasive RF ElectrodeThermgen, L.L.C20176—