secwatch.observer — SEC 8-K summary
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Issuer:     Apyx Medical Corp (APYX)
CIK:        0000719135
Form:       8-K
Filed at:   2022-07-18T23:59:59+00:00
Accession:  0000719135-22-000058
Event type: regulatory
Sentiment:  positive
Materiality: 0.75
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/719135/000071913522000058/0000719135-22-000058-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/719135/000071913522000058/apyx-20220718.htm
  HTML page:      https://secwatch.observer/filing/0000719135-22-000058

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer