For a beauty-device classification request, the main challenge is not the number of files but whether every file describes the same product. An independent reviewer should be able to reconstruct the device, its output, its contact with the body and its intended purpose.
1. Product overview
Explain the components, accessories and software, the energy or physical action used, how each mode starts, how energy reaches the body and what the product is intended to achieve. Describe every handpiece and mode rather than only the lowest-risk function.
2. Technical requirements
Convert key outputs and safety controls into measurable specifications. RF devices may need frequency, power, electrode configuration and temperature control; microcurrent devices need current, voltage, waveform, frequency and load; ultrasound devices need frequency, intensity and continuous or pulsed operation.
3. Images, videos and instructions
These materials must show the real structure, interface, handpieces, operating steps and body contact. Model numbers, levels, accessories, parameters, areas and operating time must match across all documents.
4. Supporting tests
Testing should address the actual regulatory uncertainty, such as temperature rise, electrical stimulation, output stability, depth of action, skin integrity, ozone or optical energy. The purpose is to verify key statements, not to accumulate reports.
5. Submission check
- Freeze one application model and production version.
- Use a single master parameter table.
- Align the name, intended use and warnings.
- Check images, software screens and accessories.
- Cover normal and worst-case use.
- Obtain approval from R&D, regulatory, marketing and management.
A specific product can only be assessed from its complete and consistent technical record.