Background
The product used 27 MHz RF energy in an aesthetic-care setting. The company needed to clarify its regulatory status in China and resolve the relationship among RF terminology, actual parameters and intended purpose.
Main Challenges
- The RF mechanism could easily be confused with medical-aesthetic devices
- Purpose, delivery claims and parameters needed one consistent product logic
- Skin temperature rise, use duration and safety controls required supporting evidence
Basic Law’s Work
The project systematically reviewed the actual product structure, operating principle, output parameters, intended purpose, risk controls and verification evidence, and supported the classification-determination submission and supplementary responses.
Project Significance
RF terminology alone does not determine regulatory status. A viable non-medical route depends on overall consistency among purpose, parameters, method of action, risk and evidence.
This page presents only authorised public information and does not disclose client trade secrets, full submission dossiers, critical raw test data, or directly replicable parameter boundaries. Ongoing project content reflects only the current stage; product status must still be independently assessed based on actual purpose, structure, parameters, and evidence.