510(k) Report

Devices descending from K003092

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K200241TempSure SystemCynosure, LLC202013—
+11K183450EmBody SystemInmode MD, Ltd.20198—
+11K180406Ellipse YdunEllipse A/S20180—
+11K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+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—
+12K242553MIRARI® Cold Plasma System ( GV-M2-01)General Vibronics, Inc.20240—
+12K240991eMVFit (MVF-10M)Weero Co., Ltd.20240—
+12K240780InMode RF SystemInMode, Ltd.20243—
+12K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+12K212891TempSure SystemCynosure, LLC20221—
+12K213344BTL-899ABTL Industries, Inc.20222—
+12K210129RF Thermal SystemLuvo Medical Technologies, Inc.20211—
+12K210877Evolve System with the T3 ApplicatorInMode, Ltd.20215—
+12K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd.20216—
+12K172376Discovery Pico, Discovery Pico PlusQuanta System Spa201720—
+13K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+13K241433EVE Synergy (EVE-20M)Weero Co., Ltd.20251—
+13K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.20251—
+13K243737Inbella RF SystemInbella Medical, Inc.20250—
+13K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+13K230467BTL-899FBTL Industries, Inc.20231—
+13K230167BACK 4Swims America Corp20230—
+13K230037BACK 3Swims America Corp20230—
+13K223292TempSure SystemCynosure, LLC20220—
+13K213889PicoStarAsclepion Laser Technologies GmbH20220—
+13K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa201918—
+14K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.20250—
+14K202503ChromeQuanta System Spa202012—
+15K253765Vanish ProDdc Technologies, Inc.20260—
+15K241527Pastelle ProWontech Co., Ltd.20253—
+15K223404Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4VQuanta System Spa20230—
+15K213726PL-1 Skin Treatment SystemAVAVA, Inc.20220—
+15K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+16K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical Incorporated20250—