FDA product code NOI: Stand, Instrument, Ophthalmic, Battery Powered
NOI is the FDA product code for stand, instrument, ophthalmic, battery powered. It is a Class I device, regulated under 21 CFR 886.1860 and reviewed by the Ophthalmic panel. Devices under NOI reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
AC-powered or non-powered device intended to store ophthalmic instruments in a readily accessible position.
Classification
| Field | Value |
|---|---|
| Device name | Stand, Instrument, Ophthalmic, Battery Powered |
| Device class | Class I |
| Regulation | 21 CFR 886.1860 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for NOI devices
openFDA lists no recalls for product code NOI.
Frequently asked questions
What is FDA product code NOI?
NOI is the FDA product code for stand, instrument, ophthalmic, battery powered. It is a Class I device, regulated under 21 CFR 886.1860 and reviewed by the Ophthalmic panel.
What device class is NOI?
Class I, regulation 21 CFR 886.1860. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code NOI
- Run a recall and safety report across every NOI manufacturer
- Watch product code NOI 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.