510(k) Report

Devices descending from K060484

115 later devices reach Erbe Vio Esu, Model Vio 300 D through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K223222Plasma IQNeauvia North America, Inc.20233—
+6K221830Apyx One ConsoleApyx Medical Corporation20220—
+6K220970Renuvion APR HandpieceApyx Medical Corporation (Formerly Bovie Medical Corporation)20223—
+6K202880J-Plasma Precise FLEX HandpieceApyx Medical Corporation (Formerly Bovie Medical Corporation20210—
+6K191484Renuvion/J-Plasma Precise HandpieceApyx Medical Corporation (Formerly Bovie Medical Corporation)20190—
+6K191601Valleylab FT10 Electrosurgical PlatformCovidien201911
+6K183107Intuitive Surgical Vessel Sealer ExtendIntuitive Surgical, Inc.20186—
+7K251334New Doublo 2.0Hironic Co., Ltd.20250—
+7K250674Vessel Sealer Curved (480522)Intuitive Surgical, Inc.20250—
+7K241099Plasonic (Plasonic)Hironic Co., Ltd.20242—
+7K241085Valleylab ™FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN)Covidien, LLC20240—
+7K230272Renuvion® APR HandpieceApyx Medical Corporation20231—
+7K223262Renuvion® APR HandpieceApyx Medical Corporation20232—
+8K260397SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002)Hironic Co., Ltd.20260—
+8K230586Renuvion® Micro HandpieceApyx Medical Corporation20230—