Device details
FDA 510(k) registration fields
- K number
- K251049
- Device name
- SurgiLight 1470 Diode Laser System (Model:Halo)
- Country / region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2025-04-03
- Decision date
- 2025-07-02
- Submission type
- Traditional
- Technology type
- Diode(AI inferred)
- Clinical applications
- Surgical cutting
- Primary application
- Surgical cutting
- Classification source
- AI classified
