{"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","discovered_at":"2026-05-14T18:04:03.462164+00:00","generated_at":"2026-06-25T06:57:20.227084+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Apyx Medical gets FDA 510(k) clearance for Renuvion dermal resurfacing handpiece","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0000719135-22-000040","json":"https://secwatch.observer/filing/0000719135-22-000040.json","markdown":"https://secwatch.observer/filing/0000719135-22-000040.md","text":"https://secwatch.observer/filing/0000719135-22-000040.txt","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"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-25T06:57:20.227084+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}