FDA product code HKT: Prism, Fresnel, Ophthalmic
HKT is the FDA product code for prism, fresnel, ophthalmic. It is a Class I device, regulated under 21 CFR 886.1655 and reviewed by the Ophthalmic panel. Devices under HKT reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Prism, Fresnel, Ophthalmic |
| Device class | Class I |
| Regulation | 21 CFR 886.1655 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for HKT devices
openFDA lists no recalls for product code HKT.
Frequently asked questions
What is FDA product code HKT?
HKT is the FDA product code for prism, fresnel, ophthalmic. It is a Class I device, regulated under 21 CFR 886.1655 and reviewed by the Ophthalmic panel.
What device class is HKT?
Class I, regulation 21 CFR 886.1655. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code HKT
- Run a recall and safety report across every HKT manufacturer
- Watch product code HKT 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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