FDA product code HPI: Aid, Vision, Optical, Ac-Powered
HPI is the FDA product code for aid, vision, optical, ac-powered. It is a Class I device, regulated under 21 CFR 886.5915 and reviewed by the Ophthalmic panel. Devices under HPI reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Aid, Vision, Optical, Ac-Powered |
| Device class | Class I |
| Regulation | 21 CFR 886.5915 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Recalls for HPI devices
openFDA lists no recalls for product code HPI.
Frequently asked questions
What is FDA product code HPI?
HPI is the FDA product code for aid, vision, optical, ac-powered. It is a Class I device, regulated under 21 CFR 886.5915 and reviewed by the Ophthalmic panel.
What device class is HPI?
Class I, regulation 21 CFR 886.5915. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code HPI
- Run a recall and safety report across every HPI manufacturer
- Watch product code HPI 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.