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..
FDA 510(k) Cleared Ophthalmic Femtosecond Laser Devices (Product Code OOE)
About Product Code OOE - Regulatory Context
510(k) Submission Activity
47 total 510(k) submissions under product code OOE since 2009, with 47 receiving FDA clearance (average review time: 133 days).
Submission volume has declined in recent years - 2 submissions in the last 24 months compared to 4 in the prior period.
FDA Review Time
Recent submissions under OOE have taken an average of 81 days to reach a decision - down from 136 days historically, suggesting improved FDA processing for this classification.
OOE devices are reviewed by the Ophthalmic panel. Browse all Ophthalmic devices →