FDA Product Code OOE: Ophthalmic Femtosecond Laser
Precise Cutting Or Ablation Of Ocular Tissue, Indicated For The Anterior Capsulotomy During Cataract Surgery.
Leading manufacturers include Alcon Laboratories, Inc..
2
Total
2
Cleared
81d
Avg days
2025
Since
List of Ophthalmic Femtosecond Laser devices cleared through 510(k)
2 devices
Cleared
Sep 24, 2025
LenSx Laser System (8065000944)
Alcon Laboratories, Inc.
Ophthalmic
30d
Cleared
Apr 28, 2025
LenSx Laser System (8065998162)
Alcon Laboratories, Inc.
Ophthalmic
131d
How to use this database
This page lists all FDA 510(k) submissions for Ophthalmic Femtosecond Laser devices (product code OOE). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Ophthalmic FDA review panel. Browse all Ophthalmic devices →