Device details
FDA 510(k) registration fields
- K number
- K253007
- Device name
- Laser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); Laser Fiber (PT-OF-C-S); Laser Fiber (PT-OF-D-S); Laser Fiber (PT-OF-E-S); Laser Fiber (PT-OF-F-S)
- Country / region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2025-09-19
- Decision date
- 2025-11-20
- Submission type
- Traditional
- Technology type
- Laser fiber / delivery(AI inferred)
- Clinical applications
- Surgical cuttingOther
- Primary application
- Surgical cutting
- Classification source
- AI classified
