FDA product code HQS: Burr, Corneal, Ac-Powered
HQS is the FDA product code for burr, corneal, ac-powered. It is a Class I device, regulated under 21 CFR 886.4070 and reviewed by the Ophthalmic panel. FDA has cleared 1 510(k) submission under HQS. The average 510(k) review took 305 days (median 305).
Classification
| Field | Value |
|---|---|
| Device name | Burr, Corneal, Ac-Powered |
| Device class | Class I |
| Regulation | 21 CFR 886.4070 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HQS clearance
Top HQS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medjet, Inc. | 1 | 1998-01-23 |
Most recent HQS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K971078 | Medjet, Inc. | HYDROBRUSH (TM) KERATOME | 1998-01-23 | 305 |
Recalls for HQS devices
openFDA lists no recalls for product code HQS.
Frequently asked questions
What is FDA product code HQS?
HQS is the FDA product code for burr, corneal, ac-powered. It is a Class I device, regulated under 21 CFR 886.4070 and reviewed by the Ophthalmic panel.
What device class is HQS?
Class I, regulation 21 CFR 886.4070. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HQS?
Across 1 cleared submissions the average was 305 days from receipt to decision (median 305).
Which companies have the most HQS clearances?
Medjet, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HQS
- Run a recall and safety report across every HQS manufacturer
- Watch product code HQS 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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