FDA product code NIC: Lens, Contact, For Reading Discomfort
NIC is the FDA product code for lens, contact, for reading discomfort. 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 NIC. The average 510(k) review took 304 days (median 304).
Definition
This lens is indicated for daily wear for the correction of refractive ametropia in persons with non-diseased eyes. This lens may also be prescribed as a colored filter to aid individuals who experience reading discomfort not related to binocular vision problems or uncorrected refractive error.
Classification
| Field | Value |
|---|---|
| Device name | Lens, Contact, For Reading Discomfort |
| 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 NIC clearance
Top NIC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cantor & Nissel , Ltd. | 1 | 2002-05-09 |
Most recent NIC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K012132 | Cantor & Nissel , Ltd. | CHROMAGEN V3.0 READING AID SOFT CONTACT LENS | 2002-05-09 | 304 |
Recalls for NIC devices
openFDA lists no recalls for product code NIC.
Frequently asked questions
What is FDA product code NIC?
NIC is the FDA product code for lens, contact, for reading discomfort. It is a Class II device, regulated under 21 CFR 886.5925 and reviewed by the Ophthalmic panel.
What device class is NIC?
Class II, regulation 21 CFR 886.5925. Typical premarket route: 510(k).
How long does a 510(k) take for product code NIC?
Across 1 cleared submissions the average was 304 days from receipt to decision (median 304).
Which companies have the most NIC clearances?
Cantor & Nissel , Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NIC
- Run a recall and safety report across every NIC manufacturer
- Watch product code NIC 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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