FDA product code · General, Plastic Surgery · Class 2
OLI: Fat Reducing Low Level Laser
OLI is FDA's product code for "Fat Reducing Low Level Laser": a Class 2 device classified under 21 CFR 878.5400, reviewed by the General, Plastic Surgery panel.
510(k) review time for OLI
Across 15 510(k) clearances under OLI decided from 2018-01-01 to 2026-10-06, the median was 119 days from FDA receipt to decision. Half took between 62 and 176 days, and 80% were decided within 227 days. These are past clearances, not a forecast for a new submission.
| Fastest | 29 |
|---|---|
| 25th percentile | 62 |
| Median | 119 |
| 75th percentile | 176 |
| 80th percentile | 227 |
| 90th percentile | 310 |
| Slowest | 424 |
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.
OLI in the public FDA record
| 510(k) clearances, all years | 33 |
|---|
Counts of records, not of devices or events. Adverse event reports for OLI 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 OLI
2 FDA recognized consensus standards cite OLI, among them IEC 60601-2-57 Edition 1.0 2011-01; IEC 60601-2-57 Edition 2.0 2023-07. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 12-242 IEC 60601-2-57 Edition 1.0 2011-01 — Medical Electrical Equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic diagnostic monitoring and cosmetic/aesthetic use
- 12-355 IEC 60601-2-57 Edition 2.0 2023-07 — Medical Electrical Equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic diagnostic monitoring cosmetic and aesthetic use
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.