DeviceClearance

Product code OOE— Ophthalmic

Catalys Precision Laser System

Classification name
Ophthalmic Femtosecond Laser
Device class
Class 2
Regulation
21 CFR 886.4390
Advisory panel
Ophthalmic
Total cleared
47
First cleared
Most recent

FDA classification definition

“Precise cutting or ablation of ocular tissue, indicated for the anterior capsulotomy during cataract surgery.”

— U.S. Food and Drug Administration, device classification record for product code OOE under 21 CFR 886.4390, via openFDA

Market context for product code OOE

FDA has cleared 47 devices under product code OOE between 2009 and 2025, filed by 12 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code OOE

Adverse events under product code OOE

product code OOE
Injury
1,104
Malfunction
864
Total
1,968

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code OOE

Data sourced from openFDA. This site is unofficial and independent of the FDA.