FDA product code HRE: Cabinet, Instrument, Ac-Powered, Ophthalmic
HRE is the FDA product code for cabinet, instrument, ac-powered, ophthalmic. It is a Class I device, regulated under 21 CFR 886.1860 and reviewed by the Ophthalmic panel. Devices under HRE reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Cabinet, Instrument, Ac-Powered, Ophthalmic |
| Device class | Class I |
| Regulation | 21 CFR 886.1860 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Recalls for HRE devices
openFDA lists no recalls for product code HRE.
Frequently asked questions
What is FDA product code HRE?
HRE is the FDA product code for cabinet, instrument, ac-powered, ophthalmic. It is a Class I device, regulated under 21 CFR 886.1860 and reviewed by the Ophthalmic panel.
What device class is HRE?
Class I, regulation 21 CFR 886.1860. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code HRE
- Run a recall and safety report across every HRE manufacturer
- Watch product code HRE 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.