Device details
FDA 510(k) registration fields
- K number
- K192483
- Device name
- MeDioStar
- Country / region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2019-09-10
- Decision date
- 2020-03-13
- Submission type
- Special
- Technology type
- Diode(AI inferred)
- Clinical applications
- Hair removalPigment treatmentVascular treatment
- Primary application
- Hair removal
- Classification source
- AI classified
