510(k) Report

Devices descending from K850668

1,030 later devices reach Electrosurgical Unit 774 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+14K242553MIRARI® Cold Plasma System ( GV-M2-01)General Vibronics, Inc.20240—
+14K240991eMVFit (MVF-10M)Weero Co., Ltd.20240—
+14K240780InMode RF SystemInMode, Ltd.20243—
+14K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+14K230124LUSTRE ClearSkin Renew Pro Facewear Mask (Model: PR4001)Light Tree Ventures Europe B.V.202310—
+14K212891TempSure SystemCynosure, LLC20221—
+14K213344BTL-899ABTL Industries, Inc.20222—
+14K210129RF Thermal SystemLuvo Medical Technologies, Inc.20211—
+14K210877Evolve System with the T3 ApplicatorInMode, Ltd.20215—
+14K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd.20216—
+14K172376Discovery Pico, Discovery Pico PlusQuanta System Spa201720—
+15K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+15K241433EVE Synergy (EVE-20M)Weero Co., Ltd.20251—
+15K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.20251—
+15K243737Inbella RF SystemInbella Medical, Inc.20250—
+15K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+15K230467BTL-899FBTL Industries, Inc.20231—
+15K230167BACK 4Swims America Corp20230—
+15K230037BACK 3Swims America Corp20230—
+15K223292TempSure SystemCynosure, LLC20220—
+15K213889PicoStarAsclepion Laser Technologies GmbH20220—
+15K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa201918—
+16K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.20250—
+16K202503ChromeQuanta System Spa202012—
+17K253765Vanish ProDdc Technologies, Inc.20260—
+17K241527Pastelle ProWontech Co., Ltd.20253—
+17K223404Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4VQuanta System Spa20230—
+17K213726PL-1 Skin Treatment SystemAVAVA, Inc.20220—
+17K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+18K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical Incorporated20250—