Device details
FDA 510(k) registration fields
- K number
- K220268
- Device name
- Picosecond Laser System (Model PS10-A and PS10-B)
- Country / region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2022-01-31
- Decision date
- 2022-08-23
- Submission type
- Traditional
- Technology type
- Picosecond(AI inferred)
- Clinical applications
- Pigment treatment
- Primary application
- Pigment treatment
- Classification source
- AI classified
