Classification, testing and instructions are built around a defined product version. If a company uses a low-output sample to obtain a result and later raises output, adds functions or changes claims, the filing facts and sales facts separate.
1. Potentially material differences
- RF power, frequency, temperature control or electrode design.
- Microcurrent voltage, current, waveform or programs.
- Ultrasound transducer, acoustic output or mode.
- New handpieces, accessories or companion liquids.
- App-based unlocking of new functions.
- Target users, body area or intended purpose.
- Manufacturer, model or critical materials.
2. The same model name is not enough
A company can change the board, software, sensor or handpiece without changing the model label. Authorities and business partners look at the substantive product, not only the printed identifier.
3. Practical consequences
A platform may find page functions outside the result; a complaint sample may not match the file; distributors may suffer losses from unsupported claims; and an inspection may reveal unexplained version changes. Administrative, contractual and reputational risks can arise together.
4. Establish a product baseline
- Photograph and record the serial number of the assessed sample.
- Freeze hardware, software, handpieces and output matrix.
- Preserve technical requirements, instructions and test versions.
- Use formal engineering-change approval.
- Assess every change for action, purpose and risk.
- Audit production and retain measured data.
5. What to do after a mismatch
Stop expanding the difference, freeze the current market version, create a comparison matrix and assess whether the original result remains applicable. Minor changes may be documented; changes affecting energy, purpose or risk may require new testing, classification assessment or market-route adjustment.
Consistency management ensures that the product sold is the same product that was evaluated and verified.