FDA product code · Ophthalmic · Class 2
OOE: Ophthalmic Femtosecond Laser
OOE is FDA's product code for "Ophthalmic Femtosecond Laser": a Class 2 device classified under 21 CFR 886.4390, reviewed by the Ophthalmic panel.
510(k) review time for OOE
Across 15 510(k) clearances under OOE decided from 2018-01-01 to 2026-10-06, the median was 118 days from FDA receipt to decision. Half took between 82 and 130 days, and 80% were decided within 132 days. These are past clearances, not a forecast for a new submission.
| Fastest | 29 |
|---|---|
| 25th percentile | 82 |
| Median | 118 |
| 75th percentile | 130 |
| 80th percentile | 132 |
| 90th percentile | 154 |
| Slowest | 168 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
OOE in the public FDA record
| 510(k) clearances, all years | 47 |
|---|---|
| Device recalls | 8 |
Counts of records, not of devices or events. Adverse event reports for OOE are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.
FDA-recognized standards that cite OOE
No FDA recognized consensus standard cites OOE by product code. Horizontal standards such as biocompatibility, sterilization and software standards can still apply.
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.