FDA product code NUU: Lens, Contact, Orthokeratology, Overnight
NUU is the FDA product code for lens, contact, orthokeratology, overnight. It is a Class III device, regulated under 21 CFR 886.5916 and reviewed by the Ophthalmic panel. Devices under NUU reach the market by PMA; FDA lists no cleared 510(k)s for it. 7 PMA applications cite this product code. FDA has posted 2 recalls for NUU devices, 2 initiated in the last five years.
Definition
Temporary reduction of myopia or refractive error.
Classification
| Field | Value |
|---|---|
| Device name | Lens, Contact, Orthokeratology, Overnight |
| Device class | Class III |
| Regulation | 21 CFR 886.5916 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | PMA |
Recalls for NUU devices
2 product recalls in 1 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2023-06-26.
| Year | Recalls |
|---|---|
| 2023 | 2 |
Frequently asked questions
What is FDA product code NUU?
NUU is the FDA product code for lens, contact, orthokeratology, overnight. It is a Class III device, regulated under 21 CFR 886.5916 and reviewed by the Ophthalmic panel.
What device class is NUU?
Class III, regulation 21 CFR 886.5916. Typical premarket route: PMA.
Have NUU devices been recalled?
Yes: 2 product recalls across 1 recall events; the most recent began 2023-06-26.
Next steps
- Run an FDA pathway report with predicate devices for product code NUU
- Run a recall and safety report across every NUU manufacturer
- Watch product code NUU 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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