# K984219: Colormax Color Vision Enhancement Lenses

- Pathway: 510(k) (Traditional)
- Applicant: Color Vision Technologies, Inc.
- Decided: Nov 18, 1999 after 358 days
- Product code: NAI (Lens, Prescription, Color Deficiency)
- Device class: 1
- Regulation: 21 CFR 886.5844
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Prescription Spectacle Lenses: named in the summary without a submission number

## Indications for use
ColorMax Lenses are prescription spectacle lenses that are indicated for use as an optical aid for Deutan and Protan color vision deficiences.

Source page: https://510kreport.com/device/K984219
Methodology: https://510kreport.com/methodology