regulatory
confidence high
sentiment neutral
materiality 0.60
Apyx submits 510(k) for AYON Body Contouring System; ahead of schedule
Apyx Medical Corp
- 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.