K251759
- 510(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
- Applicant
- Boston Scientific Corporation MA · US
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2025-07-09
- Date received
- 2025-06-09
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K251759.pdf
Official FDA record: K251759
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.