Device details
FDA 510(k) registration fields
- K number
- K251759
- Device name
- Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser Fiber; Flexiva Pulse ID TracTip Laser Fibers
- Country / region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2025-06-09
- Decision date
- 2025-07-09
- Submission type
- Special
- Technology type
- Laser fiber / delivery(AI inferred)
- Clinical applications
- Surgical cuttingOtherVascular treatmentAcne treatment
- Primary application
- Surgical cutting
- Classification source
- AI classified
