secwatch.observer — SEC 8-K summary
======================================

Issuer:     Apyx Medical Corp (APYX)
CIK:        0000719135
Form:       8-K
Filed at:   2025-01-06T23:59:59+00:00
Accession:  0001437749-25-000375
Event type: regulatory
Sentiment:  neutral
Materiality: 0.60
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Apyx submits 510(k) for AYON Body Contouring System; ahead of schedule
----------------------------------------------------------------------

- Submitted 510(k) premarket notification to FDA for AYON Body Contouring System.
- AYON integrates infiltration, dual aspiration, ultrasound liposuction, electrocoagulation, volume enhancement, Renuvion skin tightening.
- Company plans a second 510(k) later in 2025 for power-assisted liposuction.
- Submission completed ~90 days earlier than originally expected, per CEO.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/719135/000143774925000375/0001437749-25-000375-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/719135/000143774925000375/apyx20250103c_8k.htm
  HTML page:      https://secwatch.observer/filing/0001437749-25-000375

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