510(k) Report

Devices descending from K081939

4 later devices reach Omniguide Beampath Fiber Optic Handpiece System and Sterilization Tray through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K183199TRIO HandpieceOmniguide, Inc.20190—
+1K140378Flexguide Ultra Beampath Robotic Fiber ConduitOmniguide, Inc.20142—
+2K170777Bovie J-Plasma Precise FLEX HandpieceBovie Medical Corporation20171—
+3K202880J-Plasma Precise FLEX HandpieceApyx Medical Corporation (Formerly Bovie Medical Corporation20210—