Device details
FDA 510(k) registration fields
- K number
- K231896
- Device name
- Diode Laser Therapy System
- Country / region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2023-06-28
- Decision date
- 2024-02-20
- Submission type
- Traditional
- Technology type
- Diode(AI inferred)
- Clinical applications
- Hair removalVascular treatment
- Primary application
- Hair removal
- Classification source
- AI classified
