Device details
FDA 510(k) registration fields
- K number
- K200751
- Device name
- Photodynamic Therapy (PDT) Equipment
- Country / region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2020-03-23
- Decision date
- 2020-05-21
- Submission type
- Traditional
- Technology type
- LED(AI inferred)
- Clinical applications
- Acne treatmentVascular treatmentPigment treatmentOther
- Primary application
- Acne treatment
- Classification source
- AI classified
