NIC
- Product code
- NIC
- Device name
- Lens, Contact, For Reading Discomfort
- Device class
- Class 2
- 21 CFR
- 21 CFR 886.5925
- Medical specialty
- Ophthalmic
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (all years, FDA)
- 1 (all years; only the last 3 years are listed here)
FDA classification 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.
Official FDA classification page: NIC
Classification and pathway per current FDA publications. Data from openFDA (CC0).