NIC — Lens, Contact, For Reading Discomfort Class II
FDA product code NIC covers "Lens, Contact, For Reading Discomfort", a Class II medical device regulated under 21 CFR 886.5925. Submissions are reviewed by the Ophthalmic panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- NIC
- Device Class
- Class II
- Regulation Number
- 886.5925
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K012132 | cantor and nissel | CHROMAGEN V3.0 READING AID SOFT CONTACT LENS | May 9, 2002 |