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FDA 510(k)

Apyx One Console

K-Number: K221830 · 2022-10-11

ApplicantApyx Medical Corporation
Decision Date2022-10-11
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Apyx One Console is the device name listed in this FDA 510(k) record. The listed applicant is Apyx Medical Corporation. It received FDA 510(k) clearance on 2022-10-11 under 510(k) number K221830. 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 One Console?

Apyx One Console is a medical device that received FDA 510(k) clearance on 2022-10-11. The listed applicant is Apyx Medical Corporation. The 510(k) number is K221830.

When did Apyx One Console receive FDA 510(k) clearance?

Apyx One Console received FDA 510(k) clearance on 2022-10-11, under 510(k) number K221830.

Who is the listed applicant for Apyx One Console?

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

What is the FDA product code for Apyx One Console?

The FDA product code for Apyx One Console is GEI.

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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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