# K973934: Sunglasses

- Pathway: 510(k) (Traditional)
- Applicant: Elegance Optical Manufactory, Ltd.
- Decided: Nov 18, 1997 after 34 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
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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Intended to be worn by a person to protect the eyes from bright sunlight but not to provide refractive corrections.

Source page: https://510kreport.com/device/K973934
Methodology: https://510kreport.com/methodology