FDA product code HPB: Clip, Lens, Trial, Ophthalmic
HPB is the FDA product code for clip, lens, trial, ophthalmic. It is a Class I device, regulated under 21 CFR 886.1410 and reviewed by the Ophthalmic panel. Devices under HPB reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Clip, Lens, Trial, Ophthalmic |
| Device class | Class I |
| Regulation | 21 CFR 886.1410 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Recalls for HPB devices
openFDA lists no recalls for product code HPB.
Frequently asked questions
What is FDA product code HPB?
HPB is the FDA product code for clip, lens, trial, ophthalmic. It is a Class I device, regulated under 21 CFR 886.1410 and reviewed by the Ophthalmic panel.
What device class is HPB?
Class I, regulation 21 CFR 886.1410. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code HPB
- Run a recall and safety report across every HPB manufacturer
- Watch product code HPB 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.
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