Do Not Start with Wording
Whether an RF product is a medical device must be assessed from the actual product. The name and claims are only part of the evidence and cannot override hardware parameters or the mechanism of action.
What Must Be Reviewed Together
- RF frequency, waveform, output power and energy
- Electrode structure, contact area, treatment area and duration
- Skin temperature rise, abnormal-condition protection and worst-case use
- Intended purpose, instructions, distribution training and e-commerce claims
If these elements cannot jointly support a non-medical aesthetic positioning, the company should adjust the product or use the medical-device pathway.
This article provides general compliance information and cannot replace a formal assessment of a specific product. Regulations, classification catalogues, guidance, and enforcement practice may change; each project should rely on the rules then in effect, the actual product, and formal documents.