Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Apyx Medical Corporation · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
122 daysmedian FDA review time
220 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253396 | AYON Body Contouring System™ (AYON SYSTEM) | Apyx Medical Corporation | 2026-05-08 | 220 | 0 |
| K244050 | AYON Body Contouring System (AYON SYSTEM) | Apyx Medical Corporation | 2025-05-12 | 132 | 0 |
| K230586 | Renuvion® Micro Handpiece | Apyx Medical Corporation | 2023-06-09 | 99 | 0 |
| K230272 | Renuvion® APR Handpiece | Apyx Medical Corporation | 2023-04-27 | 86 | 0 |
| K223262 | Renuvion® APR Handpiece | Apyx Medical Corporation | 2023-02-23 | 122 | 0 |
| K221830 | Apyx One Console | Apyx Medical Corporation | 2022-10-11 | 110 | 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