FDA product code NCZ: Lens, Contact, For Color Vision Deficiency
NCZ is the FDA product code for lens, contact, for color vision deficiency. It is a Class II device, regulated under 21 CFR 886.5925 and reviewed by the Ophthalmic panel. FDA has cleared 1 510(k) submission under NCZ. The average 510(k) review took 303 days (median 303).
Classification
| Field | Value |
|---|---|
| Device name | Lens, Contact, For Color Vision Deficiency |
| Device class | Class II |
| Regulation | 21 CFR 886.5925 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every NCZ clearance
Top NCZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cantor & Silver , Ltd. | 1 | 2000-10-20 |
Most recent NCZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K994320 | Cantor & Silver , Ltd. | CHROMAGEN V2.0 HAPLOSCOPIC SYSTEM & COLOR VISION ENHANCEMENT SOFT CONTACT LENSES | 2000-10-20 | 303 |
Recalls for NCZ devices
openFDA lists no recalls for product code NCZ.
Frequently asked questions
What is FDA product code NCZ?
NCZ is the FDA product code for lens, contact, for color vision deficiency. It is a Class II device, regulated under 21 CFR 886.5925 and reviewed by the Ophthalmic panel.
What device class is NCZ?
Class II, regulation 21 CFR 886.5925. Typical premarket route: 510(k).
How long does a 510(k) take for product code NCZ?
Across 1 cleared submissions the average was 303 days from receipt to decision (median 303).
Which companies have the most NCZ clearances?
Cantor & Silver , Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NCZ
- Run a recall and safety report across every NCZ manufacturer
- Watch product code NCZ 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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