10xAnd
Scoping review

FDA product code · General, Plastic Surgery · Class 2

OAP: Laser, Comb, Hair

OAP is FDA's product code for "Laser, Comb, Hair": a Class 2 device classified under 21 CFR 890.5500, reviewed by the General, Plastic Surgery panel.

510(k) review time for OAP

Across 78 510(k) clearances under OAP decided from 2018-01-01 to 2026-10-06, the median was 89 days from FDA receipt to decision. Half took between 72 and 126 days, and 80% were decided within 146 days. These are past clearances, not a forecast for a new submission.

Days from FDA receipt to 510(k) decision, OAP, decisions 2018-01-01 to 2026-10-06 (n = 78)
Fastest25
25th percentile72
Median89
75th percentile126
80th percentile146
90th percentile227
Slowest402
Median days by decision year, OAP (years with enough clearances to compute). The partial final year counts only submissions already decided, so its median runs low.
YearMedian daysn
20188715
2019899
2020889
2021895
2022998
2023818
20249410
2025876
2026 (to 10-06, partial)858

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.

OAP in the public FDA record

Records naming OAP, from openFDA (snapshot of 2026-09-15)
510(k) clearances, all years112
Establishment listings137

Counts of records, not of devices or events. Adverse event reports for OAP 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 OAP

No FDA recognized consensus standard cites OAP 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.

Related product codes