510(k) Report

Devices descending from K972267

31 later devices reach Helica TC through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090586Bovie Icon GS Electrosurgical Generator (GS100), Handpiece (GS-OP-R), Reusable Handpiece…Bovie Medical200916—
+1K032969Helica TC Laparoscopic Cutting and Cauterising (LTC) ProbeHelica Instruments, Ltd.200415—
+2K142975Bovie Ultimate High Frequency Electrosurgical GeneratorBovie Medical Corporation201412—
+2K112233Bovie J-Plasma Handpiece with Retractable Cutting BladeBovie Medical Corporation201214—
+2K050541Omniguide Beampath CO2 Mark I Laser Beam DeliveryOmniguide Communications, Inc.200514—
+3K170188Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency…Bovie Medical Corporation2017116
+3K151325Bovie J-Plasma HandpieceBovie Medical Corporation2015131
+3K073313Mark Iii Waveguide Fiber with Low Profile TipOmniguide, Inc.20085—
+3K070157Omniguide Beam Path CO2 Mark Iii Waveguide FiberOmniguide, Inc.200781
+3K063141Omniguide Zero Flow ZF-T 150 Waveguide FiberOmniguide, Inc.20061—
+3K062423Omniguide Beampath Laser Beam Delivery SystemOmniguide, Inc.20061—
+3K061909Highland Beam Delivery System, Model 3-099-002-00-00Omniguide, Inc.20062—
+4K203241OmniGuide BeamPath OTO-U FiberOmniguide, Inc.20210—
+4K192867Apyx Helium Plasma Generator (APYX-200H/P, APYX-JS3/RS3)Bovie Medical Corporation Dba Apyx Medical Corporation20191—
+4K191542Apyx Plasma/RF HandpieceBovie Medical Corporation Dba Apyx Medical Corporation20194—
+4K191484Renuvion/J-Plasma Precise HandpieceApyx Medical Corporation (Formerly Bovie Medical Corporation)20190—
+4K183610Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open handpieces…Bovie Medical Corporation201961
+4K170777Bovie J-Plasma Precise FLEX HandpieceBovie Medical Corporation20171—
+4K152570Bovie J-Plasma Precise 360 HandpieceBovie Medical Corporation2015125
+4K140378Flexguide Ultra Beampath Robotic Fiber ConduitOmniguide, Inc.20142—
+4K112166Ultralase Flexible CO2 Laser WaveguideW and R Investments Dba Laser Engineering20111—
+4K093451Omniguide Beampath CO2 Mark Iii Waveguide Fiber with Low Profile/Low Loss TipOmniguide, Inc.20094—
+4K073409Omniguide Sterile Waveguide Adapter SystemOmniguide, Inc.20070—
+4K070071Omniguide Zero Flow ZF-T Waveguide FiberOmniguide, Inc.20070—
+5K221830Apyx One ConsoleApyx Medical Corporation20220—
+5K220970Renuvion APR HandpieceApyx Medical Corporation (Formerly Bovie Medical Corporation)20223—
+5K211761UltraLase Flexible CO2 Laser WaveguideW & R Investments, LLC Dba Laser Engineering20210—
+5K202880J-Plasma Precise FLEX HandpieceApyx Medical Corporation (Formerly Bovie Medical Corporation20210—
+6K230272Renuvion® APR HandpieceApyx Medical Corporation20231—
+6K223262Renuvion® APR HandpieceApyx Medical Corporation20232—
+7K230586Renuvion® Micro HandpieceApyx Medical Corporation20230—