NJH — Lens, Spectacle (Prescription), For Reading Discomfort Class I
FDA product code NJH covers "Lens, Spectacle (Prescription), For Reading Discomfort", a Class I medical device regulated under 21 CFR 886.5844. Submissions are reviewed by the Ophthalmic panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NJH
- Device Class
- Class I
- Regulation Number
- 886.5844
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
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.