K240615
- 510(k) number
- K240615
- Device name
- Leos Laser and Endoscopy System
- Applicant
- Beaver-Visitec International, Inc. MA · US
- Product code
- HQF — Laser, Ophthalmic
- Decision date
- 2025-04-03
- Date received
- 2024-03-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ophthalmic
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K240615.pdf
Official FDA record: K240615
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.