FDA product code · General, Plastic Surgery · Class 2
LEJ: Booth, Sun Tan
LEJ is FDA's product code for "Booth, Sun Tan": a Class 2 device classified under 21 CFR 878.4635, reviewed by the General, Plastic Surgery panel.
510(k) review time for LEJ
Across 11 510(k) clearances under LEJ decided from 2018-01-01 to 2026-10-06, the median was 109 days from FDA receipt to decision. Half took between 98 and 177 days, and 80% were decided within 224 days. These are past clearances, not a forecast for a new submission.
| Fastest | 45 |
|---|---|
| 25th percentile | 98 |
| Median | 109 |
| 75th percentile | 177 |
| 80th percentile | 224 |
| 90th percentile | 265 |
| Slowest | 1,093 |
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.
LEJ in the public FDA record
| 510(k) clearances, all years | 81 |
|---|---|
| GUDID device identifiers | 1,742 |
Counts of records, not of devices or events. Adverse event reports for LEJ 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 LEJ
No FDA recognized consensus standard cites LEJ 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.