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FDA product code · General, Plastic Surgery · Class 2

OHS: Light Based Over The Counter Wrinkle Reduction

OHS is FDA's product code for "Light Based Over The Counter Wrinkle Reduction": a Class 2 device classified under 21 CFR 878.4810, reviewed by the General, Plastic Surgery panel.

510(k) review time for OHS

Across 130 510(k) clearances under OHS decided from 2018-01-01 to 2026-10-06, the median was 90 days from FDA receipt to decision. Half took between 81 and 124 days, and 80% were decided within 142 days. These are past clearances, not a forecast for a new submission.

Days from FDA receipt to 510(k) decision, OHS, decisions 2018-01-01 to 2026-10-06 (n = 130)
Fastest24
25th percentile81
Median90
75th percentile124
80th percentile142
90th percentile183
Slowest456
Median days by decision year, OHS (years with enough clearances to compute). The partial final year counts only submissions already decided, so its median runs low.
YearMedian daysn
2018847
20211627
202212916
202310112
20248716
20258942
2026 (to 10-06, partial)8824

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.

OHS in the public FDA record

Records naming OHS, from openFDA (snapshot of 2026-09-15)
510(k) clearances, all years163
Establishment listings279
GUDID device identifiers398

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

4 FDA recognized consensus standards cite OHS, 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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