K252682

LenSx Laser System (8065000944)

510(k) number
K252682
Device name
LenSx Laser System (8065000944)
Applicant
Alcon Laboratories, Inc. TX · US
Product code
OOE — Ophthalmic Femtosecond Laser
Decision date
2025-09-24
Date received
2025-08-25
Decision
Substantially Equivalent
Clearance type
Special
Advisory committee
Ophthalmic
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain

Also available from FDA: K252682.pdf

Official FDA record: K252682
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.