510(k) Report

Devices descending from K982816

973 later devices reach Vnus Closure System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K230373HELIOS 785 PicoLaseroptek Co., Ltd.20232—
+9K230351LED Facial MaskShenzhen Sungpo Hi-Tech Electronic Co., Ltd.202333—
+9K230819OmniGuide RFID Surgical Laser FibersOmni-Guide Holdings, Inc.20230—
+9K221775LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003)Light Tree Ventures Europe B.V.20227—
+9K221946LED Light Therapy Mask (model: MK66R-B)Light Tree Ventures Europe B.V.202218—
+9K221574LUDWIG Electrosurgical DeviceAesthetics Biomedical20220—
+9K220853PicoWay Laser SystemCandela Corporation20221—
+9K213120OW100S (model OW100S-US)Tissue Regeneration Technologies, LLC Dba AS Softwave Trt20220—
+9K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+9K221151Beauty LED Mask, Model: KFB265Hunan Guangye Biotechnology Co., Ltd.202241—
+9K210084SilkroHironic Co., Ltd.20223—
+9K220793InnoVoyce Laser FiberInnovoyce, LLC20220—
+9K220592Venus BlissMAXVenus Concept USA, Inc.20221—
+9K220124YandR System, VoluDerm Handpiece, VoluDerm TipsPollogen, Ltd.20220—
+9K212127PicocaremajestyWontech Co., Ltd.20226—
+9K213184MZ Skin LightMAX Supercharged LED Mask 2.0Mz Skin202135—
+9K212107ReversoIntelis Instruments, Ltd.20211—
+9K201773PicohiHironic Co., Ltd.20215—
+9K211821DEKA Motus AZEl.En Electronic Engineering Spa20211—
+9K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+9K203491PicoLO Nd: YAG Picosecond Laser SystemLaseroptek Co., Ltd.20211—
+9K201387Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc.20210—
+9K203665STOP U Model UXV DevicePollogen, Ltd.20214—
+9K201685PotenzaJeisys Medical, Inc.20219—
+9K201735PlaDuo SystemShenB Co., Ltd.20203—
+9K200947InMode System with the Morhpeus8 ApplicatorsInMode, Ltd.202015—
+9K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—
+9K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+9K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+9K192224BTL-899Btl20198—
+9K191855EmFace DeviceInmode MD, Ltd.20191—
+9K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+9K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+9K181095RF-ReliefEl Global Trade, Ltd.20181—
+9K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+9K180709truSculpt RF Device; truSculpt; truSculpt 3DCutera, Inc.20183—
+9K173677InMode VLazeInmode MD, Ltd.20183—
+9K173582ThermiX Temperature Control Radiofrequency System, Accessories - RF ElectrodesThermigen, L.L.C20181—
+9K172302InMode PLUS SystemInmode MD, Ltd.201713—
+9K171262TempSureCynosure, Inc.201716—
+9K172004truSculptCutera, Inc.20173—
+9K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+9K171094Thermi Reusable Non-invasive RF ElectrodeThermgen, L.L.C20176—
+9K163222Discovery Pico FamilyQuanta System Spa201630—
+9K162781Magma SparkFormatk Systems, Ltd.20160—
+9K161403A.R.C. Laser Surgical Fibers and ProbesA.R.C Laser GmbH20160—
+9K161661Thermi RF AccessoriesThermi20163—
+9K152731XP1100 RFBTL Industries, Inc.20160—
+9K151793InMode RF SystemInmode MD, Ltd.20161—
+9K150907Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner…Ellipse A/S20155—
+10K261851LED Light Therapy Mask (JML1, JML1+JML2); LED Light Therapy Mask (JML3, JML3+JML4); LED…Shenzhen Qianyu Technology Co., Ltd.20260—
+10K260138LUNE PureHygieneEnamel Pure20260—
+10K260017Picosecond Nd:YAG Laser Systems (Model: HS-298)Shanghai Apolo Medical Technology Co., Ltd.20260—
+10K253829Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+10K254290ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Shenzhen Peninsula Medical Group20260—
+10K252753Vydence Family of LasersVydence Medical Industria E Commercio Ltda20260—
+10K252745Halo Sterile Single-use Radial Fiber…Micro-Energy Medical Technology Co., Ltd.20251—
+10K253007Laser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); Laser Fiber (PT-OF-C-S); Laser Fiber…Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.20250—
+10K252447Picosecond laser device (BMPS4)Hebei Newangie Technology Co., Ltd.20250—
+10K252096Light Therapy Decollete Mask (1019135)Merchsource, LLC20250—
+10K250734OptiLUV DevicePollogen, Ltd.20250—
+10K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—
+10K250966CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+10K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+10K242755Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE…Gigaalaser Company, Ltd.20251—
+10K243176BLESSING SystemCellah Medical Co., Ltd.20251—
+10K250041Medical Picosecond ND: YAG Laser System (PZ-6)Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+10K250809Stellar M22Lumenis Be, Ltd.20250—
+10K242068LED Light Therapy Mask (RT01)Ningbo Dechang Electrical Machinery Made Co.,Ltd20250—
+10K250113neoLaser Laser Surgery FibersG.N.S Neolaser, Ltd.20250—
+10K250281Deka LotusEl.En S.P.A.20250—
+10K250200InbellaBody SystemInbella Medical, Inc.20250—
+10K242941CO2 Laser Therapy Systems (SHE-LSP003-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+10K243929Oligio XWontech Co., Ltd.20250—
+10K243040LED Light Therapy Mask…Shenzhen Siken 3D Technology Development Co., Ltd.20241—
+10K231216PotenzaJeisys Medical, Inc.20244—
+10K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+10K231287PotenzaJeisys Medical, Inc.20241—
+10K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+10K241144Picosecond Nd:YAG Laser (PICOCAREMAJESTY)Wontech Co., Ltd.20241—
+10K233123SilkroHironic Co., Ltd.20241—
+10K241459MOTUS PRO FamilyEl.En S.P.A.20240—
+10K233007Picosecond Nd:YAG Laser System; PICO LEGENDAmi, Inc.20241—
+10K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—
+10K233099GladiatorRohrer Aesthetics, LLC20240—
+10K240752Deka ToroEl.En S.P.A.20240—
+10K240999Legend X Applicator VOPollogen, Ltd.20241—
+10K240118Picosecond Nd:YAG Laser SystemSmedtrum Medical Technology Co., Ltd.20240—
+10K234104PICOANDY (Q-Switched Nd:YAG Laser)Wontech Co., Ltd.20242—
+10K230837PlazMagikAgnes Medical Co., Ltd.20240—
+10K233143PiXel8-RevealRohrer Aesthetics20240—
+10K233114LED silicone mask (Model: LP-RVTGLWP-WHT, LP-RVTGLW-WHT, TLM200)Shenzhen Idea Light Limited20241—
+10K233018PICOSECOND Nd:YAG Laser SystemIds, Ltd.20232—
+10K233147PiXel8-RFRohrer Aesthetics20230—
+10K232223PlaDuo SystemShenB Co., Ltd.20230—
+10K231790The InMode System with the Morpheus8 ApplicatorsInMode, Ltd.202310—
+10K222790F65 Laser SystemLumenis Be, Ltd.20233—
+10K220322Pollogen STOP U Model UXV DevicePollogen, Ltd.20233—
+10K222260Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500Capenergy Medical S.L.20233—
+10K222709Retraction, CWM-910T, APOLEX TiteChungwoo Co., Ltd.20230—