K243896
- 510(k) number
- K243896
- Device name
- LenSx Laser System (8065998162)
- Applicant
- Alcon Laboratories, Inc. TX · US
- Product code
- OOE — Ophthalmic Femtosecond Laser
- Decision date
- 2025-04-28
- Date received
- 2024-12-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ophthalmic
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K243896.pdf
Official FDA record: K243896
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.