Device details
FDA 510(k) registration fields
- K number
- K252345
- Device name
- Picosecond Laser Device (PF131-BI)
- Country / region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2025-07-28
- Decision date
- 2025-10-23
- Submission type
- Traditional
- Technology type
- Picosecond(AI inferred)
- Clinical applications
- Pigment treatment
- Primary application
- Pigment treatment
- Classification source
- AI classified
