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FDA 510(k)

J-Plasma Precise FLEX Handpiece

K-Number: K202880 · 2021-01-04

ApplicantApyx Medical Corporation (Formerly Bovie Medical Corporation
Decision Date2021-01-04
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

J-Plasma Precise FLEX Handpiece is the device name listed in this FDA 510(k) record. The listed applicant is Apyx Medical Corporation (Formerly Bovie Medical Corporation. It received FDA 510(k) clearance on 2021-01-04 under 510(k) number K202880. 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 J-Plasma Precise FLEX Handpiece?

J-Plasma Precise FLEX Handpiece is a medical device that received FDA 510(k) clearance on 2021-01-04. The listed applicant is Apyx Medical Corporation (Formerly Bovie Medical Corporation. The 510(k) number is K202880.

When did J-Plasma Precise FLEX Handpiece receive FDA 510(k) clearance?

J-Plasma Precise FLEX Handpiece received FDA 510(k) clearance on 2021-01-04, under 510(k) number K202880.

Who is the listed applicant for J-Plasma Precise FLEX Handpiece?

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

What is the FDA product code for J-Plasma Precise FLEX Handpiece?

The FDA product code for J-Plasma Precise FLEX Handpiece is GEI.

Other records listing Apyx Medical Corporation (Formerly Bovie 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.

K220970Renuvion APR HandpieceK211652Renuvion Dermal Handpiece, Renuvion Dermal SystemK191484Renuvion/J-Plasma Precise Handpiece

Related Devices (Code: 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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