secwatch.observer — SEC 8-K summary
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Issuer:     Apyx Medical Corp (APYX)
CIK:        0000719135
Form:       8-K
Filed at:   2022-05-26T23:59:59+00:00
Accession:  0000719135-22-000040
Event type: regulatory
Sentiment:  positive
Materiality: 0.75
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/719135/000071913522000040/0000719135-22-000040-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/719135/000071913522000040/apyx-20220526.htm
  HTML page:      https://secwatch.observer/filing/0000719135-22-000040

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