Lens, Contact, For Reading Discomfort

NIC · Class II — Moderate Risk (510(k) clearance required) · Ophthalmic · 21 CFR 886.5925

Classification

FDA Product Code: NIC
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 886.5925
Review panel: OP
Medical specialty: Ophthalmic
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: Y

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.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 1

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown