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FDA 510(k)

Apyx Plasma/RF Handpiece

K-Number: K191542 · 2019-10-11

ApplicantBovie Medical Corporation Dba Apyx Medical Corporation
Decision Date2019-10-11
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Apyx Plasma/RF Handpiece is the device name listed in this FDA 510(k) record. The listed applicant is Bovie Medical Corporation Dba Apyx Medical Corporation. It received FDA 510(k) clearance on 2019-10-11 under 510(k) number K191542. 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 Apyx Plasma/RF Handpiece?

Apyx Plasma/RF Handpiece is a medical device that received FDA 510(k) clearance on 2019-10-11. The listed applicant is Bovie Medical Corporation Dba Apyx Medical Corporation. The 510(k) number is K191542.

When did Apyx Plasma/RF Handpiece receive FDA 510(k) clearance?

Apyx Plasma/RF Handpiece received FDA 510(k) clearance on 2019-10-11, under 510(k) number K191542.

Who is the listed applicant for Apyx Plasma/RF Handpiece?

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

What is the FDA product code for Apyx Plasma/RF Handpiece?

The FDA product code for Apyx Plasma/RF Handpiece is GEI.

Other records listing Bovie Medical Corporation Dba Apyx Medical Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K192867Apyx Helium Plasma Generator (APYX-200H/P, APYX-JS3/RS3)

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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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