Apyx Medical Corporation: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Apyx Medical Corporation” (first 2022, latest 2026), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 110 days. Since 2017 the median was 110 days, against 112 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2022 | 1 | 110 |
| 2023 | 3 | 99 |
| 2024 | 0 | — |
| 2025 | 1 | 132 |
| 2026 | 2 | 156 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Apyx Medical Corporation took a median 110 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 112 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 4 | 4 |
| QPB | System, Suction, Lipoplasty For Removal | 3 | 3 |
Review panels
Most recent Apyx Medical Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261710 | AYON Power Liposuction Cannulas and AYON Power Liposuction Cannula Adaptors | QPB | 2026-08-21 | 91 |
| K253396 | AYON Body Contouring System (AYON SYSTEM) | QPB | 2026-05-08 | 220 |
| K244050 | AYON Body Contouring System (AYON SYSTEM) | QPB | 2025-05-12 | 132 |
| K230586 | Renuvion® Micro Handpiece | GEI | 2023-06-09 | 99 |
| K230272 | Renuvion® APR Handpiece | GEI | 2023-04-27 | 86 |
| K223262 | Renuvion® APR Handpiece | GEI | 2023-02-23 | 122 |
| K221830 | Apyx One Console | GEI | 2022-10-11 | 110 |
Recalls
openFDA lists no recalls under a recalling firm named Apyx Medical Corporation.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Apyx Medical Corporation is the lead sponsor of 10 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT06243744: Histological Evaluation of Human Skin Bx to Assess the Effects of APR Tx as an Adjunct Procedure in Facelift Surgery (Completed, started 2023-11-30)
- NCT05968495: Measuring Renuvion Soft Tissue Contraction Using Ultrasound (Completed, started 2023-06-01)
- NCT05323630: Evaluation of the Use of the Renuvion APR System in the Labia (Completed, started 2023-04-19)
- NCT05665335: A Post-Market Study in Greece of a Minimally Invasive Breast Lift Procedure Utilizing the Renuvion APR System (Completed, started 2022-11-28)
- NCT05605691: Post-Market Lower Eyelid Treatment With Renuvion in Greece (Completed, started 2022-10-11)
SEC filings
Apyx Medical Corp (APYX): EDGAR filings, CIK 719135. An SEC registrant with the same name, matched by name only.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Apyx Medical Corporation(Formerly Bovie Medical Corporation) (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Apyx Medical Corporation?
FDA lists 7 510(k) clearances under the applicant name “Apyx Medical Corporation” (first 2022, latest 2026), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Apyx Medical Corporation?
The median time from FDA receipt to decision across 510(k)s cleared under the name Apyx Medical Corporation is 110 days. Since 2017: 110 days, versus 112 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Apyx Medical Corporation?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 4); QPB (System, Suction, Lipoplasty For Removal, 3).
Next steps
- See all 7 Apyx Medical Corporation clearances with predicates and recalls
- Run predicate analysis for product code GEI, Apyx Medical Corporation's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.