NJH
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Lens, Spectacle (Prescription), For Reading Discomfort
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.5844
- Medical specialty
- Ophthalmic
- FDA 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.
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| Record | Firm | Date |
|---|---|---|
| CHROMAGEN V3.0 READING AID & COLOR DISCRIMINATION ENHANCEMENT SPECTACLE LENS (K022373) | Cantor & Nissel , Ltd. | 2002-10-07 |
| PY-RITE (K853758) | Golden Dental Products, Inc. | 1985-12-03 |
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Every clearance here is in the API, with alerts when new ones post.