510(k) Report

Devices descending from K003092

736 later devices reach Modification to Vnus Closure System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+10K252345Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd.20250—
+10K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices 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—
+10K250809Stellar M22Lumenis Be, Ltd.20250—
+10K243630Medical Laser System Incanto / Evoline Platinum /EvolineSolar LS Cjsc20250—
+10K250113neoLaser Laser Surgery FibersG.N.S Neolaser, Ltd.20250—
+10K243957PicoalexWontech Co., 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—
+10K242534HandPICO Fractional Laser Handpiece TipVydence Medical20241—
+10K231216PotenzaJeisys Medical, Inc.20244—
+10K231287PotenzaJeisys Medical, Inc.20241—
+10K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+10K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+10K233123SilkroHironic Co., Ltd.20241—
+10K241407Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)Bios S.R.L.20240—
+10K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—
+10K233099GladiatorRohrer Aesthetics, LLC20240—
+10K240386Picosecond Nd:YAG Laser Systems (BL-C10)Shanghai Bele Medical Technology Co.,Ltd20240—
+10K240999Legend X Applicator VOPollogen, Ltd.20241—
+10K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+10K230837PlazMagikAgnes Medical Co., Ltd.20240—
+10K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+10K233143PiXel8-RevealRohrer Aesthetics20240—
+10K233147PiXel8-RFRohrer Aesthetics20230—
+10K232223PlaDuo SystemShenB Co., Ltd.20230—
+10K231790The InMode System with the Morpheus8 ApplicatorsInMode, Ltd.202310—
+10K222790F65 Laser SystemLumenis Be, Ltd.20233—
+10K230373HELIOS 785 PicoLaseroptek Co., Ltd.20232—
+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—
+10K222221Deka HelixEl.En Electronic Engineering Spa20231—
+10K220853PicoWay Laser SystemCandela Corporation20221—
+10K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+10K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+10K221407truSculpt iDCutera, Inc.20222—
+10K212472AgeJetTriworks Group Srl20220—
+10K211000AcutronIlooda Co,., Ltd.20220—
+10K212127PicocaremajestyWontech Co., Ltd.20226—
+10K201773PicohiHironic Co., Ltd.20215—
+10K211821DEKA Motus AZEl.En Electronic Engineering Spa20211—
+10K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+10K203491PicoLO Nd: YAG Picosecond Laser SystemLaseroptek Co., Ltd.20211—
+10K202199BTL-899STBtl20216—
+10K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—
+10K191855EmFace DeviceInmode MD, Ltd.20191—
+10K190678TempSureCynosure, Inc.201914—
+10K182365TempSure SystemCynosure, Inc.201815—
+10K181095RF-ReliefEl Global Trade, Ltd.20181—
+10K173677InMode VLazeInmode MD, Ltd.20183—
+10K172302InMode PLUS SystemInmode MD, Ltd.201713—
+10K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+10K170116Thermi Injectable RF ElectrodesThermi20172—
+10K163190InMode RF SystemInmode MD, Ltd.20160—
+10K163222Discovery Pico FamilyQuanta System Spa201630—
+10K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+11K254185Potenza PrimeJeisys Medical Incorporated20260—
+11K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+11K253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.20260—
+11K253484Lutronic GeniusCynosure Lutronic Technology Corporation20260—
+11K261701Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8)Micro-Energy Medical Technology Co., Ltd.20260—
+11K253803MILAN SystemLumenis Be, Ltd.20260—
+11K260017Picosecond Nd:YAG Laser Systems (Model: HS-298)Shanghai Apolo Medical Technology Co., Ltd.20260—
+11K253965CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight…Wuhan PHOMED Technology Company, Ltd.20260—
+11K253829Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+11K251435InbellaIgnite RF SystemInbella Medical, Inc.20260—
+11K252753Vydence Family of LasersVydence Medical Industria E Commercio Ltda20260—
+11K251254Ignite RF SystemInMode, Ltd.20260—
+11K250341Sensilift Pro (ST300XXYYZZZ)El Global Trade, Ltd.20260—
+11K252367InbellaMulti SystemInbella Medical, Inc.20250—
+11K252447Picosecond laser device (BMPS4)Hebei Newangie Technology Co., Ltd.20250—
+11K251334New Doublo 2.0Hironic Co., Ltd.20250—
+11K250734OptiLUV DevicePollogen, Ltd.20250—
+11K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+11K250041Medical Picosecond ND: YAG Laser System (PZ-6)Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+11K242469RFMagik LiteAgnes Medical Co., Ltd.20252—
+11K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+11K242349FoLixLumenis Be, Ltd.20240—
+11K241144Picosecond Nd:YAG Laser (PICOCAREMAJESTY)Wontech Co., Ltd.20241—
+11K241459MOTUS PRO FamilyEl.En S.P.A.20240—
+11K233007Picosecond Nd:YAG Laser System; PICO LEGENDAmi, Inc.20241—
+11K240752Deka ToroEl.En S.P.A.20240—
+11K233766Geneo X ElitePollogen, Ltd.20240—
+11K240118Picosecond Nd:YAG Laser SystemSmedtrum Medical Technology Co., Ltd.20240—
+11K233642InMode RF SystemInMode, Ltd.20244—
+11K234104PICOANDY (Q-Switched Nd:YAG Laser)Wontech Co., Ltd.20242—
+11K232424CurrentBody Skin RFEl Global Trade, Ltd.20240—
+11K233018PICOSECOND Nd:YAG Laser SystemIds, Ltd.20232—
+11K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+11K223110truSculpt iDCutera, Inc.20221—
+11K220268Picosecond Laser System (Model PS10-A and PS10-B)Beijing Adss Development Co., Ltd.20221—
+11K212573PicoLO PremiumLaseroptek Co., Ltd.20210—
+11K211107BTL-899 FPBTL Industries, Inc.20213—