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FDA 510(k)

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

K-Number: K192867 · 2019-10-31

ApplicantBovie Medical Corporation Dba Apyx Medical Corporation
Decision Date2019-10-31
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Apyx Helium Plasma Generator (APYX-200H/P, APYX-JS3/RS3) 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 2019-10-31 under 510(k) number K192867. 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 Helium Plasma Generator (APYX-200H/P, APYX-JS3/RS3)?

Apyx Helium Plasma Generator (APYX-200H/P, APYX-JS3/RS3) is a medical device that received FDA 510(k) clearance on 2019-10-31. The listed applicant is Bovie Medical Corporation Dba Apyx Medical Corporation. The 510(k) number is K192867.

When did Apyx Helium Plasma Generator (APYX-200H/P, APYX-JS3/RS3) receive FDA 510(k) clearance?

Apyx Helium Plasma Generator (APYX-200H/P, APYX-JS3/RS3) received FDA 510(k) clearance on 2019-10-31, under 510(k) number K192867.

Who is the listed applicant for Apyx Helium Plasma Generator (APYX-200H/P, APYX-JS3/RS3)?

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

The FDA product code for Apyx Helium Plasma Generator (APYX-200H/P, APYX-JS3/RS3) 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.

K191542Apyx Plasma/RF Handpiece

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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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