FDA product code HRO: Unit, Electrolysis, Ac-Powered, Ophthalmic
HRO is the FDA product code for unit, electrolysis, ac-powered, ophthalmic. It is a Class II device, regulated under 21 CFR 886.4250 and reviewed by the Ophthalmic panel. Devices under HRO reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Unit, Electrolysis, Ac-Powered, Ophthalmic |
| Device class | Class II |
| Regulation | 21 CFR 886.4250 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Recalls for HRO devices
openFDA lists no recalls for product code HRO.
Frequently asked questions
What is FDA product code HRO?
HRO is the FDA product code for unit, electrolysis, ac-powered, ophthalmic. It is a Class II device, regulated under 21 CFR 886.4250 and reviewed by the Ophthalmic panel.
What device class is HRO?
Class II, regulation 21 CFR 886.4250. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code HRO
- Run a recall and safety report across every HRO manufacturer
- Watch product code HRO 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.