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FDA 510(k)

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

K-Number: K183610 · 2019-03-12

ApplicantBovie Medical Corporation
Decision Date2019-03-12
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open handpieces, Renuvion/J-Plasma Precise Open handpieces is the device name listed in this FDA 510(k) record. The listed applicant is Bovie Medical Corporation. It received FDA 510(k) clearance on 2019-03-12 under 510(k) number K183610. 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 Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open handpieces, Renuvion/J-Plasma Precise Open handpieces?

Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open handpieces, Renuvion/J-Plasma Precise Open handpieces is a medical device that received FDA 510(k) clearance on 2019-03-12. The listed applicant is Bovie Medical Corporation. The 510(k) number is K183610.

When did Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open handpieces, Renuvion/J-Plasma Precise Open handpieces receive FDA 510(k) clearance?

Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open handpieces, Renuvion/J-Plasma Precise Open handpieces received FDA 510(k) clearance on 2019-03-12, under 510(k) number K183610.

Who is the listed applicant for Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open handpieces, Renuvion/J-Plasma Precise Open handpieces?

The FDA 510(k) record lists Bovie Medical Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open handpieces, Renuvion/J-Plasma Precise Open handpieces?

The FDA product code for Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open handpieces, Renuvion/J-Plasma Precise Open handpieces is GEI.

Other records listing Bovie Medical Corporation as applicant

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Official Source

View on FDA Database →

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

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