FDA product code HKF: Mirror, Headband, Ophthalmic
HKF is the FDA product code for mirror, headband, ophthalmic. It is a Class I device, regulated under 21 CFR 886.1500 and reviewed by the Ophthalmic panel. Devices under HKF reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Mirror, Headband, Ophthalmic |
| Device class | Class I |
| Regulation | 21 CFR 886.1500 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Recalls for HKF devices
openFDA lists no recalls for product code HKF.
Frequently asked questions
What is FDA product code HKF?
HKF is the FDA product code for mirror, headband, ophthalmic. It is a Class I device, regulated under 21 CFR 886.1500 and reviewed by the Ophthalmic panel.
What device class is HKF?
Class I, regulation 21 CFR 886.1500. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code HKF
- Run a recall and safety report across every HKF manufacturer
- Watch product code HKF 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.