Device details
FDA 510(k) registration fields
- K number
- K250041
- Device name
- Medical Picosecond ND: YAG Laser System (PZ-6)
- Country / region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2025-01-08
- Decision date
- 2025-05-14
- Submission type
- Traditional
- Technology type
- Picosecond(AI inferred)
- Clinical applications
- Pigment treatmentVascular treatment
- Primary application
- Pigment treatment
- Classification source
- AI classified
