FDA product code · General, Plastic Surgery · Class 2
PKT: Laser For Disruption Of Adipocyte Cells For Aesthetic Use
PKT is FDA's product code for "Laser For Disruption Of Adipocyte Cells For Aesthetic Use": a Class 2 device classified under 21 CFR 878.5400, reviewed by the General, Plastic Surgery panel.
510(k) review time for PKT
Across 14 510(k) clearances under PKT decided from 2018-01-01 to 2026-10-06, the median was 92 days from FDA receipt to decision. Half took between 80 and 186 days, and 80% were decided within 245 days. These are past clearances, not a forecast for a new submission.
| Fastest | 57 |
|---|---|
| 25th percentile | 80 |
| Median | 92 |
| 75th percentile | 186 |
| 80th percentile | 245 |
| 90th percentile | 374 |
| Slowest | 470 |
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.
FDA-recognized standards that cite PKT
No FDA recognized consensus standard cites PKT 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.