FDA product code HQE: Instrument, Vitreous Aspiration And Cutting, Ac-Powered
HQE is the FDA product code for instrument, vitreous aspiration and cutting, ac-powered. It is a Class II device, regulated under 21 CFR 886.4150 and reviewed by the Ophthalmic panel. FDA has cleared 149 510(k) submissions under HQE, 1 in the last five years, from 68 different applicants. The average 510(k) review took 114 days (median 86). FDA has posted 37 recalls for HQE devices, 4 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Instrument, Vitreous Aspiration And Cutting, Ac-Powered |
| Device class | Class II |
| Regulation | 21 CFR 886.4150 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for HQE
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 247 |
| 2022 | 1 | 344 |
Compare with all 510(k) review times · Search every HQE clearance
Top HQE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Storz Instrument Co. | 16 | 1998-03-23 |
| Medical Instrument Development Laboratories, Inc. | 13 | 2011-04-08 |
| Site Microsurgical Systems, Inc. | 7 | 1992-05-08 |
| CooperVision, Inc. | 7 | 1989-04-17 |
| Optical Micro Systems, Inc. | 6 | 1987-02-12 |
63 more applicants have HQE clearances. See the full list in Caduvo.
Most recent HQE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K212763 | Visioncare Devices, LLC | UniVit HE, UniVit UHS | 2022-08-10 | 344 |
| K170183 | A.R.C Laser GmbH | Cetus system, Cetus probe | 2017-09-27 | 247 |
| K153168 | Medical Instrument Development Laboratories | Bi-Blade Vitrectomy Cutter | 2016-04-29 | 179 |
| K141065 | Alcon Research, Ltd. | CONSTELLATION VISION SYSTEM | 2014-08-22 | 120 |
| K121675 | Synergetics, Inc. | VERSAVIT | 2012-06-21 | 15 |
Recalls for HQE devices
37 product recalls in 8 recall events; 4 initiated in the last five years and 4 still open. Most recent: 2026-04-30.
| Year | Recalls |
|---|---|
| 2018 | 13 |
| 2025 | 1 |
| 2026 | 3 |
Frequently asked questions
What is FDA product code HQE?
HQE is the FDA product code for instrument, vitreous aspiration and cutting, ac-powered. It is a Class II device, regulated under 21 CFR 886.4150 and reviewed by the Ophthalmic panel.
What device class is HQE?
Class II, regulation 21 CFR 886.4150. Typical premarket route: 510(k).
How long does a 510(k) take for product code HQE?
Across 149 cleared submissions the average was 114 days from receipt to decision (median 86).
Which companies have the most HQE clearances?
Storz Instrument Co. (16); Medical Instrument Development Laboratories, Inc. (13); Site Microsurgical Systems, Inc. (7); CooperVision, Inc. (7); Optical Micro Systems, Inc. (6).
Have HQE devices been recalled?
Yes: 37 product recalls across 8 recall events; the most recent began 2026-04-30.
Next steps
- Run an FDA pathway report with predicate devices for product code HQE
- Run a recall and safety report across every HQE manufacturer
- Watch product code HQE 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.
All Ophthalmic product codes · FDA product code lookup · 510(k) database search · 510(k) review times