RF and microcurrent combination devices are common. If both functions exist and users can access them, both must appear in the product definition and risk assessment. One vague “beauty energy” table is not enough.
1. Build two technical fact sets
RF requires frequency, power, temperature rise, electrode structure and protection. Microcurrent requires current, voltage, frequency, waveform, pulse width, load and electrode contact.
2. Independent or simultaneous operation
The user may select RF and microcurrent separately, or the program may output them at the same time. Simultaneous operation requires timing, control logic, combined energy, body circuits and fault protection. Separate tests may not represent combined use.
3. Main action and intended purpose
Explain the contribution of each energy. A product in which RF provides the main thermal action and microcurrent is secondary may be assessed differently from a microcurrent-led device. Marketing should not expand the two functions into unrelated treatment, repair, delivery and body-shaping claims.
4. Organise the file
- Functional block diagram and mode matrix.
- Separate parameter table for each energy.
- Timing of simultaneous programs.
- Handpiece and body-contact drawings.
- Single-function and combined verification.
- Modes, levels, warnings and software version.
5. Model management
If the same housing is sold as RF-only, microcurrent-only and combination versions, maintain a clear difference table. Do not use a combination result to cover a higher-output single-function product or unlock a new mode after filing.
Combination devices must be complete, truthful and verifiable. Hidden functions damage both classification and production consistency.