FDA product code NOH: Photokeratoscope, Battery Powered
NOH is the FDA product code for photokeratoscope, battery powered. It is a Class I device, regulated under 21 CFR 886.1350 and reviewed by the Ophthalmic panel. Devices under NOH reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
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Classification
| Field | Value |
|---|---|
| Device name | Photokeratoscope, 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 NOH devices
openFDA lists no recalls for product code NOH.
Frequently asked questions
What is FDA product code NOH?
NOH is the FDA product code for photokeratoscope, battery powered. It is a Class I device, regulated under 21 CFR 886.1350 and reviewed by the Ophthalmic panel.
What device class is NOH?
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 NOH
- Run a recall and safety report across every NOH manufacturer
- Watch product code NOH 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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