510(k) Report

Devices descending from K982816

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K222221Deka HelixEl.En Electronic Engineering Spa20231—
+10K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+10K220268Picosecond Laser System (Model PS10-A and PS10-B)Beijing Adss Development Co., Ltd.20221—
+10K221407truSculpt iDCutera, Inc.20222—
+10K212472AgeJetTriworks Group Srl20220—
+10K211000AcutronIlooda Co,., Ltd.20220—
+10K214103Shani Darden LED light therapy maskHarpar Grace International202219—
+10K212573PicoLO PremiumLaseroptek Co., Ltd.20210—
+10K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+10K202199BTL-899STBtl20216—
+10K190678TempSureCynosure, Inc.201914—
+10K183450EmBody SystemInmode MD, Ltd.20198—
+10K182365TempSure SystemCynosure, Inc.201815—
+10K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+10K170116Thermi Injectable RF ElectrodesThermi20172—
+10K163190InMode RF SystemInmode MD, Ltd.20160—
+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—
+11K253965CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight…Wuhan PHOMED Technology Company, Ltd.20260—
+11K251435InbellaIgnite RF SystemInbella Medical, Inc.20260—
+11K251254Ignite RF SystemInMode, Ltd.20260—
+11K250341Sensilift Pro (ST300XXYYZZZ)El Global Trade, Ltd.20260—
+11K252367InbellaMulti SystemInbella Medical, Inc.20250—
+11K251334New Doublo 2.0Hironic Co., Ltd.20250—
+11K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+11K242469RFMagik LiteAgnes Medical Co., Ltd.20252—
+11K240991eMVFit (MVF-10M)Weero Co., Ltd.20240—
+11K242349FoLixLumenis Be, Ltd.20240—
+11K233766Geneo X ElitePollogen, Ltd.20240—
+11K233642InMode RF SystemInMode, Ltd.20244—
+11K232424CurrentBody Skin RFEl Global Trade, Ltd.20240—
+11K230124LUSTRE ClearSkin Renew Pro Facewear Mask (Model: PR4001)Light Tree Ventures Europe B.V.202310—
+11K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+11K223110truSculpt iDCutera, Inc.20221—
+11K210877Evolve System with the T3 ApplicatorInMode, Ltd.20215—
+11K211107BTL-899 FPBTL Industries, Inc.20213—
+11K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd.20216—
+11K200241TempSure SystemCynosure, LLC202013—
+11K180406Ellipse YdunEllipse A/S20180—
+11K172376Discovery Pico, Discovery Pico PlusQuanta System Spa201720—
+12K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+12K252888NeoSculpt PlusS&M Medical Co., Ltd.20260—
+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—
+12K241433EVE Synergy (EVE-20M)Weero Co., Ltd.20251—
+12K242553MIRARI® Cold Plasma System ( GV-M2-01)General Vibronics, Inc.20240—
+12K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+12K240780InMode RF SystemInMode, Ltd.20243—
+12K230167BACK 4Swims America Corp20230—
+12K230037BACK 3Swims America Corp20230—
+12K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+12K213889PicoStarAsclepion Laser Technologies GmbH20220—
+12K212891TempSure SystemCynosure, LLC20221—
+12K213344BTL-899ABTL Industries, Inc.20222—
+12K210129RF Thermal SystemLuvo Medical Technologies, Inc.20211—
+12K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa201918—
+13K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.20251—
+13K243737Inbella RF SystemInbella Medical, Inc.20250—
+13K230467BTL-899FBTL Industries, Inc.20231—
+13K223292TempSure SystemCynosure, LLC20220—
+13K202503ChromeQuanta System Spa202012—
+14K253765Vanish ProDdc Technologies, Inc.20260—
+14K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.20250—
+14K241527Pastelle ProWontech Co., Ltd.20253—
+14K223404Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4VQuanta System Spa20230—
+14K213726PL-1 Skin Treatment SystemAVAVA, Inc.20220—
+14K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+15K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical Incorporated20250—