510(k) Report

FDA applicant

Apyx Medical Corporation (Formerly Bovie Medical Corporation)

Clearwater, FL4 decisions2019–20220 recalls

FDA records 4 decisions for Apyx Medical Corporation (Formerly Bovie Medical Corporation) (Clearwater, FL) from 2019 to 2022: 4 510(k) clearances. All are in product code GEI (Electrosurgical, Cutting & Coagulation &…). Since 2016 its 510(k)s took a median of 100 days from receipt to decision, against 148 for FDA’s reviews in the same codes and years. Its devices cite 5 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Apyx Medical Corporation (Formerly Bovie Medical Corporation”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Apyx Medical Corporation (Formerly Bovie Medical Corporation)’s devices, and how often a recall has named them.

FDA decisions per year

2in 2022

2019: 12021: 12022: 2
2019high 2 (2022) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Apyx Medical Corporation (Formerly Bovie Medical… by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Apyx Medical Corporation (Formerly…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • GEIElectrosurgical, Cutting & Coagulation & Accessories4decisions

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 100 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 148 days; 3 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K220970Renuvion APR HandpieceApyx Medical Corporation (Formerly Bovie Medical Corporation) · 20222cite it

What has FDA decided for it lately?

  • K220970Renuvion APR HandpieceApyx Medical Corporation (Formerly Bovie Medical Corporation) · 2022
  • K211652Renuvion Dermal Handpiece, Renuvion Dermal SystemApyx Medical Corporation (Formerly Bovie Medical Corporation · 2022
  • K202880J-Plasma Precise FLEX HandpieceApyx Medical Corporation (Formerly Bovie Medical Corporation · 2021
  • K191484Renuvion/J-Plasma Precise HandpieceApyx Medical Corporation (Formerly Bovie Medical Corporation) · 2019

All 2 as Apyx Medical Corporation (Formerly Bovie Medical Corporation) →All 2 as Apyx Medical Corporation (Formerly Bovie Medical Corporation →

Other applicant names beginning “Apyx”

FDA records each applicant name separately; these may or may not be the same firm.

Apyx Medical Corporation 7