# K971875: Optim-Eyes 450

- Pathway: 510(k) (Traditional)
- Applicant: Taylor/Fox Enterprises, LLC
- Decided: Jun 13, 1997 after 24 days
- Product code: HQY (Sunglasses (Non-Prescription Including Photosensitive))
- Device class: 1
- Regulation: 21 CFR 886.5850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K900382 (1990). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K900382: Blublocker Sunglasses, Blublocker Corp. (1990) Summary page 1.

## Indications for use
The Optim-Eyes 450 sunglasses are worn by persons to protect the eyes from bright sunlight, including 100X UVA and UVB, and blue light up to 450 nanometers.

Source page: https://510kreport.com/device/K971875
Methodology: https://510kreport.com/methodology