FDA product code HON: Perimeter, Manual
HON is the FDA product code for perimeter, manual. It is a Class I device, regulated under 21 CFR 886.1605 and reviewed by the Ophthalmic panel. Devices under HON reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Perimeter, Manual |
| Device class | Class I |
| Regulation | 21 CFR 886.1605 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for HON devices
openFDA lists no recalls for product code HON.
Frequently asked questions
What is FDA product code HON?
HON is the FDA product code for perimeter, manual. It is a Class I device, regulated under 21 CFR 886.1605 and reviewed by the Ophthalmic panel.
What device class is HON?
Class I, regulation 21 CFR 886.1605. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code HON
- Run a recall and safety report across every HON manufacturer
- Watch product code HON 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.