---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-25-016259"
form_type: "8-K"
ticker: "APYX"
cik: "0000719135"
company_name: "Apyx Medical Corp"
filed_at: "2025-05-13T23:59:59+00:00"
generated_at: "2026-05-21T19:20:51.190077+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# Apyx Medical receives FDA 510(k) clearance for AYON Body Contouring System

## Summary
- AYON is the first FDA-cleared all-in-one platform combining fat removal, contouring, tissue contraction, and electrosurgery.
- Initial clearance covers Renuvion for lax skin, ultrasound liposuction, electrocoagulation; power liposuction submission planned later in 2025.
- Commercial launch with key opinion leader surgeons in critical geographies expected in second half of 2025.
- Company highlights >15 million GLP-1 drug users as a growth driver for body contouring procedures.

## SEC filing metadata
- accession: 0001437749-25-016259
- form_type: 8-K
- ticker: APYX
- cik: 0000719135
- company_name: Apyx Medical Corp
- filed_at: 2025-05-13T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/719135/000143774925016259/0001437749-25-016259-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/719135/000143774925016259/apyx20250509_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-25-016259
- JSON: https://secwatch.observer/filing/0001437749-25-016259.json
- Plain text: https://secwatch.observer/filing/0001437749-25-016259.txt

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