FDA product code NOG: Topographer, Corneal, Battery Powered
NOG is the FDA product code for topographer, corneal, battery powered. It is a Class I device, regulated under 21 CFR 886.1350 and reviewed by the Ophthalmic panel. Devices under NOG reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
Topographer, corneal, battery powered
Classification
| Field | Value |
|---|---|
| Device name | Topographer, Corneal, Battery Powered |
| Device class | Class I |
| Regulation | 21 CFR 886.1350 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for NOG devices
openFDA lists no recalls for product code NOG.
Frequently asked questions
What is FDA product code NOG?
NOG is the FDA product code for topographer, corneal, battery powered. It is a Class I device, regulated under 21 CFR 886.1350 and reviewed by the Ophthalmic panel.
What device class is NOG?
Class I, regulation 21 CFR 886.1350. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code NOG
- Run a recall and safety report across every NOG manufacturer
- Watch product code NOG 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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