The guidance document was released on July 26, 2023. It’s the NMPA current thinking about the clinical evaluation of the Powered Laser Surgical Instrument.
This guideline applies to powered laser surgical instruments intended to reduce human hair and wrinkles, treat hyperpigmented skin diseases and skin vascular diseases, and treat scars (Product Code 09-03-01, Class III). This guideline does not apply to picosecond laser.
This guideline includes the basic requirements of the Clinical Evaluation:
1.Intended use.
2.Indications for use.
3.Target population.
4.Application sites.
5.Technical Characteristics.
6.Basic rule for choosing the predicate.
7.Support documents requirement.
8.Clinical data.
For the details, please contact GVMMEDICAL to discuss your case. info@gvmmedical.com