Lens, Contact, For Reading Discomfort
The Contact Lens for Reading Discomfort is a daily-wear soft contact lens indicated for the correction of refractive ametropia in persons with non-diseased eyes, and 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. It is classified as FDA Class 2 (Special Controls), requiring 510(k) clearance, under product code NIC and regulation 21 CFR 886.5925 in the Ophthalmic specialty. The device is eligible for third-party review and is not an implant or life-sustaining device.
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Basic Information
- Product Code
- NIC
- Device Class
- FDA class 2
- Regulation Number
- 886.5925
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K012132 | CHROMAGEN V3.0 READING AID SOFT CONTACT LENS | May 09, 2002 | Substantially Equivalent | Cantor & Nissel , Ltd. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.