# K012298: The Intuitive Colorimeter

- Pathway: 510(k) (Traditional)
- Applicant: Cerium Optical Technologies, Inc.
- Decided: Sep 26, 2001 after 68 days
- Product code: NFD (Selector, Color, Spectacle, Lens, Tint)
- Device class: 1
- Regulation: 21 CFR 886.1160
- 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) Color Vision Plate Illuminator: named in the summary without a submission number

## Indications for use
A Spectacle Lens Tint Color Selector is an AC powered device that is a variable-color illuminator box intended to simulate vision through different colors of spectacle lens tints for the purpose of selecting preferred tint(s).

Source page: https://510kreport.com/device/K012298
Methodology: https://510kreport.com/methodology