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FDA 510(k)

Renuvion/J-Plasma Precise Handpiece

K-Number: K191484 · 2019-07-30

ApplicantApyx Medical Corporation(Formerly Bovie Medical Corporation)
Decision Date2019-07-30
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Renuvion/J-Plasma Precise 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 2019-07-30 under 510(k) number K191484. 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 Renuvion/J-Plasma Precise Handpiece?

Renuvion/J-Plasma Precise Handpiece is a medical device that received FDA 510(k) clearance on 2019-07-30. The listed applicant is Apyx Medical Corporation(Formerly Bovie Medical Corporation). The 510(k) number is K191484.

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

Renuvion/J-Plasma Precise Handpiece received FDA 510(k) clearance on 2019-07-30, under 510(k) number K191484.

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

The FDA product code for Renuvion/J-Plasma Precise 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 SystemK202880J-Plasma Precise FLEX 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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