FDA product code HPD: Lens, Bagolini
HPD is the FDA product code for lens, bagolini. It is a Class I device, regulated under 21 CFR 886.1375 and reviewed by the Ophthalmic panel. Devices under HPD reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Lens, Bagolini |
| Device class | Class I |
| Regulation | 21 CFR 886.1375 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for HPD devices
openFDA lists no recalls for product code HPD.
Frequently asked questions
What is FDA product code HPD?
HPD is the FDA product code for lens, bagolini. It is a Class I device, regulated under 21 CFR 886.1375 and reviewed by the Ophthalmic panel.
What device class is HPD?
Class I, regulation 21 CFR 886.1375. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code HPD
- Run a recall and safety report across every HPD manufacturer
- Watch product code HPD 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.