510(k) Report

Devices descending from K161134

14 later devices reach Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941 Electrosurgical… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202106Plasmage SystemBrera Medical, Inc.20220—
+1K192813Plasma IQNeauvia North America, Inc.202012—
+2K210693Plexr PlusGmv S.R.L.20221—
+2K212329Plasma IQNeauvia North America, Inc.20215—
+2K201738SubNovii Advanced Plasma TechnologyCartessa Aesthetics20205—
+3K242286Superflow Prime Treatment System (ASP-1M)Guangzhou Aimira Innovation Technology Co, Ltd.20240—
+3K233123SilkroHironic Co., Ltd.20241—
+3K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+3K220493Plaxpot Multi PlasmaGcs Co. Limited20230—
+3K223440Plasma Pen (Plasma MD); Plasma Pen (Plasma +)Plasma Concepts20230—
+3K223222Plasma IQNeauvia North America, Inc.20233—
+4K251334New Doublo 2.0Hironic Co., Ltd.20250—
+4K241099Plasonic (Plasonic)Hironic Co., Ltd.20242—
+5K260397SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002)Hironic Co., Ltd.20260—