Technical and Regulatory Challenges
The regulatory status of an RF product cannot be determined from frequency terminology alone. Output form, energy, temperature rise, penetration depth, treatment duration, contact method and intended purpose must be considered together.
Common Risks
- Claims involving treatment, repair, inflammation reduction, tissue remodelling or disease
- Parameters, temperature rise or use conditions inconsistent with a non-medical aesthetic positioning
- Submission documents inconsistent with actual hardware or software-control logic
- Continued use of medical-aesthetic sales language after receiving a non-medical determination
Assessment Information
Provide circuit and electrode information, frequency and waveform, maximum output, levels, operating duration, temperature-rise testing, treatment areas and a complete use video.