Bovie J-Plasma Precise 360 Handpiece

• • Terminated Z-0198-2019 FDA Class II ·initiated 18 Jun 2018

  There is a potential risk associated with the PEEK tip of the J-Plasma Precise 360 Handpiece separating from the handpiece and retained in the tissue.

• 4 recalls, same reason

  • Terminated Z-2646-2016 FDA Class II ·initiated 18 Jul 2016
  • Terminated Z-2648-2016 FDA Class II ·initiated 18 Jul 2016
  • Terminated Z-2647-2016 FDA Class II ·initiated 18 Jul 2016
  • Terminated Z-2649-2016 FDA Class II ·initiated 18 Jul 2016

  The adhesive may be inadequately applied or the assembly may be manipulated after application of the adhesive resulting in an incomplete bond to the angled tip.

510(k) Number

K152570 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K121441 Active Cleared 20 Jul 2012

• Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open handpieces, Renuvion/J-Plasma Precise Open handpieces

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  FDA 510(k) K183610 Active Cleared 12 Mar 2019

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• Boss Coagulation Device, Model BOSS1215, Boss Coagulation Device, Angled Access, Model BOSA1215

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  FDA 510(k) K180211 Active Cleared 21 Mar 2018

See all devices from Bovie Medical Corporation →