---
schema_version: "secwatch.filing_event.v1"
accession: "0000719135-22-000040"
form_type: "8-K"
ticker: "APYX"
cik: "0000719135"
company_name: "Apyx Medical Corp"
filed_at: "2022-05-26T23:59:59+00:00"
generated_at: "2026-06-25T06:57:20.227084+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Apyx Medical gets FDA 510(k) clearance for Renuvion dermal resurfacing handpiece

## Summary
- Clearance for treatment of moderate to severe wrinkles, limited to Fitzpatrick skin types I–III.
- Addressable market of ~200,000 wrinkle reduction procedures annually in the U.S.
- Renuvion Dermal Handpiece indicated for specific dermal resurfacing procedures.
- Limited launch planned for Q3 2022; full commercialization targeted by end of 2022.
- CEO calls it 'one of the most important achievements' in the U.S. cosmetic surgery strategy.

## SEC filing metadata
- accession: 0000719135-22-000040
- form_type: 8-K
- ticker: APYX
- cik: 0000719135
- company_name: Apyx Medical Corp
- filed_at: 2022-05-26T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/719135/000071913522000040/0000719135-22-000040-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/719135/000071913522000040/apyx-20220526.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000719135-22-000040
- JSON: https://secwatch.observer/filing/0000719135-22-000040.json
- Plain text: https://secwatch.observer/filing/0000719135-22-000040.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.