FDA product code HQB: Photocoagulator And Accessories
HQB is the FDA product code for photocoagulator and accessories. It is a Class II device, regulated under 21 CFR 886.4690 and reviewed by the Ophthalmic panel. FDA has cleared 30 510(k) submissions under HQB, 1 in the last five years, from 20 different applicants. The average 510(k) review took 120 days (median 98). FDA has posted 32 recalls for HQB devices, 4 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Photocoagulator And Accessories |
| Device class | Class II |
| Regulation | 21 CFR 886.4690 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for HQB
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 2 | 192 |
| 2022 | 1 | 276 |
Compare with all 510(k) review times · Search every HQB clearance
Top HQB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Peregrine Surgical , Ltd. | 3 | 2013-11-14 |
| Gamp & Assoc. | 3 | 1995-12-22 |
| Nidek, Inc. | 3 | 1986-02-07 |
| Vortex Surgical, Inc. | 2 | 2022-11-03 |
| Surgical Laser Technologies, Inc. | 2 | 1988-12-14 |
15 more applicants have HQB clearances. See the full list in Caduvo.
Most recent HQB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K220263 | Vortex Surgical, Inc. | Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers | 2022-11-03 | 276 |
| K191846 | Vortex Surgical, Inc. | MAXReach Laser Probe | 2019-12-23 | 166 |
| K182646 | VitreQ BV | Vitreq disposable laser probes, light fibers and Chandelier | 2019-05-01 | 219 |
| K132614 | Peregrine Surgical , Ltd. | PEREGRINE CURVED ILLUMINATING LASER PROBE | 2013-11-14 | 85 |
| K122997 | Peregrine Surgical , Ltd. | 23GA CURVED ILLUMINATING LASER PROBE | 2013-06-26 | 272 |
Recalls for HQB devices
32 product recalls in 4 recall events; 4 initiated in the last five years and 4 still open. Most recent: 2025-12-16.
| Year | Recalls |
|---|---|
| 2025 | 4 |
Frequently asked questions
What is FDA product code HQB?
HQB is the FDA product code for photocoagulator and accessories. It is a Class II device, regulated under 21 CFR 886.4690 and reviewed by the Ophthalmic panel.
What device class is HQB?
Class II, regulation 21 CFR 886.4690. Typical premarket route: 510(k).
How long does a 510(k) take for product code HQB?
Across 30 cleared submissions the average was 120 days from receipt to decision (median 98).
Which companies have the most HQB clearances?
Peregrine Surgical , Ltd. (3); Gamp & Assoc. (3); Nidek, Inc. (3); Vortex Surgical, Inc. (2); Surgical Laser Technologies, Inc. (2).
Have HQB devices been recalled?
Yes: 32 product recalls across 4 recall events; the most recent began 2025-12-16.
Next steps
- Run an FDA pathway report with predicate devices for product code HQB
- Run a recall and safety report across every HQB manufacturer
- Watch product code HQB 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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