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FDA product code · Ophthalmic · Class 2

HQF: Laser, Ophthalmic

HQF is FDA's product code for "Laser, Ophthalmic": a Class 2 device classified under 21 CFR 886.4390, reviewed by the Ophthalmic panel.

510(k) review time for HQF

Across 30 510(k) clearances under HQF decided from 2018-01-01 to 2026-10-06, the median was 110 days from FDA receipt to decision. Half took between 84 and 219 days, and 80% were decided within 255 days. These are past clearances, not a forecast for a new submission.

Days from FDA receipt to 510(k) decision, HQF, decisions 2018-01-01 to 2026-10-06 (n = 30)
Fastest27
25th percentile84
Median110
75th percentile219
80th percentile255
90th percentile267
Slowest394
Median days by decision year, HQF (years with enough clearances to compute). The partial final year counts only submissions already decided, so its median runs low.
YearMedian daysn
2022867
20231555

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.

HQF in the public FDA record

Records naming HQF, from openFDA (snapshot of 2026-09-15)
510(k) clearances, all years180
Device recalls32
Establishment listings202
GUDID device identifiers2,127

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

3 FDA recognized consensus standards cite HQF, among them ANSI Z80.36-2021; ISO 10936-2 Second edition 2010-01-15; IEC 60825-1 Edition 2.0 2007-03. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.

  • 10-130 ANSI Z80.36-2021 — American National Standard for Ophthalmics - Light Hazard Protection for Ophthalmic Instruments
  • 10-66 ISO 10936-2 Second edition 2010-01-15 — Optics and photonics - Operation microscopes - Part 2: Light hazard from operation microscopes used in ocular surgery
  • 12-273 IEC 60825-1 Edition 2.0 2007-03 — Safety of laser products - Part 1: Equipment classification and requirements [Including: Technical Corrigendum 1 (2008) Interpretation Sheet 1 (2007) Interpretation Sheet 2 (2007)]

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

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