---
schema_version: "secwatch.filing_event.v1"
accession: "0000719135-22-000058"
form_type: "8-K"
ticker: "APYX"
cik: "0000719135"
company_name: "Apyx Medical Corp"
filed_at: "2022-07-18T23:59:59+00:00"
generated_at: "2026-06-24T13:41:31.152565+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Apyx Medical receives FDA 510(k) clearance for Renuvion to treat loose skin on neck and chin

## Summary
- FDA clearance for Renuvion APR Handpiece for subcutaneous procedures to improve appearance of lax skin in neck and submental region.
- Renuvion is now the only FDA-cleared device for improving loose skin on neck and chin; targets ~200,000 annual US neck contouring procedures.
- Limited launch expected by end of Q3 2022, full commercialization by end of 2022.
- Clearance supported by safety and efficacy data from a U.S. IDE clinical study; results announced July 8, 2022.
- This is the second regulatory clearance for a specific clinical indication in less than two months.

## SEC filing metadata
- accession: 0000719135-22-000058
- form_type: 8-K
- ticker: APYX
- cik: 0000719135
- company_name: Apyx Medical Corp
- filed_at: 2022-07-18T23:59:59+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/719135/000071913522000058/0000719135-22-000058-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/719135/000071913522000058/apyx-20220718.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000719135-22-000058
- JSON: https://secwatch.observer/filing/0000719135-22-000058.json
- Plain text: https://secwatch.observer/filing/0000719135-22-000058.txt

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