FDA product code HQF: Laser, Ophthalmic
HQF is the FDA product code for laser, ophthalmic. It is a Class II device, regulated under 21 CFR 886.4390 and reviewed by the Ophthalmic panel. FDA has cleared 180 510(k) submissions under HQF, 20 in the last five years, from 84 different applicants. The average 510(k) review took 125 days (median 90); 223 days on average over the last three years. 1 PMA application cites this product code. FDA has posted 32 recalls for HQF devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Laser, Ophthalmic |
| Device class | Class II |
| Regulation | 21 CFR 886.4390 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for HQF
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 3 | 176 |
| 2018 | 1 | 100 |
| 2019 | 4 | 138 |
| 2020 | 4 | 50 |
| 2021 | 1 | 119 |
| 2022 | 7 | 115 |
| 2023 | 5 | 156 |
| 2024 | 3 | 170 |
| 2025 | 3 | 266 |
| 2026 | 2 | 234 |
Compare with all 510(k) review times · Search every HQF clearance
Top HQF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Quantel Medical | 13 | 2026-02-06 |
| Lightmed Corp. | 9 | 2015-02-27 |
| Ellex Medical Pty, Ltd. | 8 | 2022-11-02 |
| Nidek, Inc. | 8 | 2002-02-11 |
| Hgm, Inc. | 6 | 1994-03-01 |
79 more applicants have HQF clearances. See the full list in Caduvo.
Most recent HQF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252979 | Belkin Vision, Ltd. | Voyager DSLT (430840610) | 2026-04-07 | 202 |
| K251507 | Quantel Medical | INTEGRE LIO | 2026-02-06 | 266 |
| K251772 | Od-Os GmbH | Navilas Laser System 577sl (156691) | 2025-10-29 | 141 |
| K243014 | Eyeq, Inc. | EyeQ nanoECP | 2025-06-18 | 264 |
| K240615 | Beaver-Visitec International, Inc. | Leos Laser and Endoscopy System | 2025-04-03 | 394 |
Recalls for HQF devices
32 product recalls in 24 recall events; 2 initiated in the last five years and 3 still open. Most recent: 2025-12-05.
| Year | Recalls |
|---|---|
| 2021 | 1 |
| 2023 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code HQF?
HQF is the FDA product code for laser, ophthalmic. It is a Class II device, regulated under 21 CFR 886.4390 and reviewed by the Ophthalmic panel.
What device class is HQF?
Class II, regulation 21 CFR 886.4390. Typical premarket route: 510(k).
How long does a 510(k) take for product code HQF?
Across 180 cleared submissions the average was 125 days from receipt to decision (median 90).
Which companies have the most HQF clearances?
Quantel Medical (13); Lightmed Corp. (9); Ellex Medical Pty, Ltd. (8); Nidek, Inc. (8); Hgm, Inc. (6).
Have HQF devices been recalled?
Yes: 32 product recalls across 24 recall events; the most recent began 2025-12-05.
Next steps
- Run an FDA pathway report with predicate devices for product code HQF
- Run a recall and safety report across every HQF manufacturer
- Watch product code HQF for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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