FDA product code HRL: Unit, Beta, Radiation, Ophthalmic
HRL is the FDA product code for unit, beta, radiation, ophthalmic. It is a Class II device, regulated under 21 CFR 886.5100 and reviewed by the Ophthalmic panel. Devices under HRL reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Unit, Beta, Radiation, Ophthalmic |
| Device class | Class II |
| Regulation | 21 CFR 886.5100 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for HRL devices
openFDA lists no recalls for product code HRL.
Frequently asked questions
What is FDA product code HRL?
HRL is the FDA product code for unit, beta, radiation, ophthalmic. It is a Class II device, regulated under 21 CFR 886.5100 and reviewed by the Ophthalmic panel.
What device class is HRL?
Class II, regulation 21 CFR 886.5100. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code HRL
- Run a recall and safety report across every HRL manufacturer
- Watch product code HRL 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.