FDA product code HOP: Campimeter, Stereo, Battery-Powered
HOP is the FDA product code for campimeter, stereo, battery-powered. It is a Class I device, regulated under 21 CFR 886.1810 and reviewed by the Ophthalmic panel. Devices under HOP reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Campimeter, Stereo, Battery-Powered |
| Device class | Class I |
| Regulation | 21 CFR 886.1810 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for HOP devices
openFDA lists no recalls for product code HOP.
Frequently asked questions
What is FDA product code HOP?
HOP is the FDA product code for campimeter, stereo, battery-powered. It is a Class I device, regulated under 21 CFR 886.1810 and reviewed by the Ophthalmic panel.
What device class is HOP?
Class I, regulation 21 CFR 886.1810. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code HOP
- Run a recall and safety report across every HOP manufacturer
- Watch product code HOP 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.