Lens, Spectacle (Prescription), For Reading Discomfort
The Spectacle Lens (Prescription) for Reading Discomfort is a colored prescription lens that may 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 1 (General Controls), subject to general controls without requiring 510(k) clearance, under product code NJH and regulation 21 CFR 886.5844 in the Ophthalmic specialty. The device is not GMP exempt, not an implant, and not life-sustaining.
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Basic Information
- Product Code
- NJH
- Device Class
- FDA class 1
- Regulation Number
- 886.5844
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 4
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 250 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 250 registration numbers. Click on an entry to view related FDA registrations.