FDA product code HKQ: Prism, Rotary, Ophthalmic
HKQ is the FDA product code for prism, rotary, ophthalmic. It is a Class I device, regulated under 21 CFR 886.1665 and reviewed by the Ophthalmic panel. Devices under HKQ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Prism, Rotary, Ophthalmic |
| Device class | Class I |
| Regulation | 21 CFR 886.1665 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for HKQ devices
openFDA lists no recalls for product code HKQ.
Frequently asked questions
What is FDA product code HKQ?
HKQ is the FDA product code for prism, rotary, ophthalmic. It is a Class I device, regulated under 21 CFR 886.1665 and reviewed by the Ophthalmic panel.
What device class is HKQ?
Class I, regulation 21 CFR 886.1665. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code HKQ
- Run a recall and safety report across every HKQ manufacturer
- Watch product code HKQ 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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