HQYClass I

Sunglasses (Non-Prescription Including Photosensitive)

21 CFR 886.5850 / Ophthalmic

HQY is the FDA product code for Sunglasses (Non-Prescription Including Photosensitive), a class I device type, regulated under 21 CFR 886.5850. As of 2026-09-10, FDA records hold 646 510(k) clearances under this code, the most recent dated 1998-01-30, and one recall.

Classification record

Product code: HQY
Device name: Sunglasses (Non-Prescription Including Photosensitive)
Regulation: 21 CFR 886.5850
Device class: Class I
Review panel: Ophthalmic
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 646
Ingested recalls: 1

Clearances, product code HQY

By decision year

646 clearances under product code HQY with a decision year between 1979 and 1998, 1994 the highest year at 211.

Show the numbers

510(k) clearances under FDA product code HQY by decision year
Year	Clearances
1979	1
1980	2
1981	2
1982	1
1983	1
1984	1
1985	9
1986	8
1987	10
1988	12
1989	8
1990	60
1991	22
1992	23
1993	66
1994	211
1995	90
1996	63
1997	51
1998	5

Applicants with the most clearances

Product code HQY

Applicants holding the most 510(k) clearances under product code HQY
Applicant	Clearances
J & B Assoc.	10
The Orvis Co., Inc.	9
Blublocker LLC	7
Sunny Sunglasses	6
Ja-Ru, Inc.	5
The Limited Stores, Inc.	5
U.S. Toy Co., Inc.	5
Walmart Stores	5
Yorktowne Optical Co., Inc.	5
Jasco Products Co., Inc.	4

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 1,411 companies shown, in name order