FDA product code · General, Plastic Surgery · Class 2
OWN: Confocal Optical Imaging
OWN is FDA's product code for "Confocal Optical Imaging": a Class 2 device classified under 21 CFR 876.1500, reviewed by the General, Plastic Surgery panel.
510(k) review time for OWN
Across 40 510(k) clearances under OWN decided from 2018-01-01 to 2026-10-06, the median was 82 days from FDA receipt to decision. Half took between 53 and 137 days, and 80% were decided within 161 days. These are past clearances, not a forecast for a new submission.
| Fastest | 21 |
|---|---|
| 25th percentile | 53 |
| Median | 82 |
| 75th percentile | 137 |
| 80th percentile | 161 |
| 90th percentile | 244 |
| Slowest | 635 |
| Year | Median days | n |
|---|---|---|
| 2019 | 81 | 7 |
| 2020 | 81 | 7 |
| 2023 | 69 | 6 |
| 2026 (to 10-06, partial) | 63 | 7 |
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.
OWN in the public FDA record
| 510(k) clearances, all years | 62 |
|---|---|
| Establishment listings | 188 |
Counts of records, not of devices or events. Adverse event reports for OWN 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 OWN
No FDA recognized consensus standard cites OWN 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.