Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Apyx Medical Corporation(Formerly Bovie Medical Corporation) · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K220970 | Renuvion APR Handpiece | Apyx Medical Corporation(Formerly Bovie Medical Corporation) | 2022-07-15 | 102 | 0 |
| K211652 | Renuvion Dermal Handpiece, Renuvion Dermal System | Apyx Medical Corporation (Formerly Bovie Medical Corporation | 2022-05-25 | 362 | 0 |
| K202880 | J-Plasma Precise FLEX Handpiece | Apyx Medical Corporation (Formerly Bovie Medical Corporation | 2021-01-04 | 98 | 0 |
| K191484 | Renuvion/J-Plasma Precise Handpiece | Apyx Medical Corporation(Formerly Bovie Medical Corporation) | 2019-07-30 | 56 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda