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FDA product code · General, Plastic Surgery · Class 2

OHT: Light Based Over-The-Counter Hair Removal

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

510(k) review time for OHT

Across 145 510(k) clearances under OHT decided from 2018-01-01 to 2026-10-06, the median was 82 days from FDA receipt to decision. Half took between 57 and 90 days, and 80% were decided within 103 days. These are past clearances, not a forecast for a new submission.

Days from FDA receipt to 510(k) decision, OHT, decisions 2018-01-01 to 2026-10-06 (n = 145)
Fastest23
25th percentile57
Median82
75th percentile90
80th percentile103
90th percentile147
Slowest266
Median days by decision year, OHT (years with enough clearances to compute). The partial final year counts only submissions already decided, so its median runs low.
YearMedian daysn
2018898
2019647
20218912
20227025
20238332
20246226
20258725
2026 (to 10-06, partial)809

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.

OHT in the public FDA record

Records naming OHT, from openFDA (snapshot of 2026-09-15)
510(k) clearances, all years163
Establishment listings220
GUDID device identifiers586

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

4 FDA recognized consensus standards cite OHT, 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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