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FDA product code · General, Plastic Surgery · Class 2

OLP: Over-The-Counter Powered Light Based Laser For Acne

OLP is FDA's product code for "Over-The-Counter Powered Light Based Laser For Acne": a Class 2 device classified under 21 CFR 878.4810, reviewed by the General, Plastic Surgery panel.

510(k) review time for OLP

Across 26 510(k) clearances under OLP decided from 2018-01-01 to 2026-10-06, the median was 129 days from FDA receipt to decision. Half took between 87 and 259 days, and 80% were decided within 262 days. These are past clearances, not a forecast for a new submission.

Days from FDA receipt to 510(k) decision, OLP, decisions 2018-01-01 to 2026-10-06 (n = 26)
Fastest55
25th percentile87
Median129
75th percentile259
80th percentile262
90th percentile266
Slowest449
Median days by decision year, OLP (years with enough clearances to compute). The partial final year counts only submissions already decided, so its median runs low.
YearMedian daysn
20181045
20212606
20222455

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.

OLP in the public FDA record

Records naming OLP, from openFDA (snapshot of 2026-09-15)
510(k) clearances, all years51
Establishment listings197

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

4 FDA recognized consensus standards cite OLP, among them ANSI IES RP-27.2-00/R17; IEC 62471 First edition 2006-07; ANSI IES RP-27.1-2015. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.

  • 12-102 ANSI IES RP-27.2-00/R17 — Recommended Practice for Photobiological Safety for Lamps and Lamp Systems - Measurement Techniques
  • 12-249 IEC 62471 First edition 2006-07 — Photobiological safety of lamps and lamp systems
  • 12-297 ANSI IES RP-27.1-2015 — Recommended Practice for Photobiological Safety for Lamps and Lamp Systems - General Requirements
  • 12-321 ANSI IES RP-27.3-17 — Recommended Practice for Photobiological Safety for Lamps - Risk Group Classification and Labeling

Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.

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