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FDA 510(k)

Bovie J-Plasma Precise FLEX Handpiece

K-Number: K170777 · 2017-05-01

ApplicantBovie Medical Corporation
Decision Date2017-05-01
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Bovie J-Plasma Precise FLEX Handpiece is a medical device manufactured by Bovie Medical Corporation. It received FDA 510(k) clearance on 2017-05-01 under approval number K170777. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bovie J-Plasma Precise FLEX Handpiece?

Bovie J-Plasma Precise FLEX Handpiece is a medical device that received FDA 510(k) clearance on 2017-05-01. It is manufactured by Bovie Medical Corporation. The 510(k) number is K170777.

When was Bovie J-Plasma Precise FLEX Handpiece approved by the FDA?

Bovie J-Plasma Precise FLEX Handpiece received FDA 510(k) clearance on 2017-05-01, under approval number K170777.

What company makes Bovie J-Plasma Precise FLEX Handpiece?

Bovie J-Plasma Precise FLEX Handpiece is manufactured by Bovie Medical Corporation.

What is the FDA product code for Bovie J-Plasma Precise FLEX Handpiece?

The FDA product code for Bovie J-Plasma Precise FLEX Handpiece is GEI.

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Other Devices by Bovie Medical Corporation

K161558Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating, Bovie 2.4mm Disposable Bipolar Ablator 55°, Non-Aspirating, Bovie 1.8mm Disposable Bipolar Ablator 60°, Non-Aspirating K161134Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941 Electrosurgical Generator, Bovie DERM 942 Electrosurgical Generator K152777Bovie Disposable Bipolar Ablator K170188Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency Electrosurgical Generator K183610Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open handpieces, Renuvion/J-Plasma Precise Open handpieces

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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