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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 a medical device manufactured by Bovie Medical Corporation Dba Apyx Medical Corporation. It received FDA 510(k) clearance on 2019-10-31 under approval 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. It is manufactured by Bovie Medical Corporation Dba Apyx Medical Corporation. The 510(k) number is K192867.

When was Apyx Helium Plasma Generator (APYX-200H/P, APYX-JS3/RS3) approved by the FDA?

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

What company makes Apyx Helium Plasma Generator (APYX-200H/P, APYX-JS3/RS3)?

Apyx Helium Plasma Generator (APYX-200H/P, APYX-JS3/RS3) is manufactured by Bovie Medical Corporation Dba Apyx Medical Corporation.

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.

Related Clinical Trials

NCT07564739 Study of Tolerance to the Application of Cold Plasma in the Treatment of Chronic Wounds RECRUITING

Other Devices by Bovie Medical Corporation Dba Apyx Medical Corporation

K191542Apyx Plasma/RF Handpiece

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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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