Lens, Spectacle (Prescription), For Reading Discomfort

NJH · Class I — Low Risk (general controls) · Ophthalmic · 21 CFR 886.5844

Classification

FDA Product Code: NJH
Device class: Class I — Low Risk (general controls)
Regulation: 21 CFR 886.5844
Review panel: OP
Medical specialty: Ophthalmic
Submission type: 4
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

Colored spectacle lenses 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: 2
Registered establishments: 240

Source

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