HQY · Class I · 21 CFR 886.5850

FDA Product Code HQY: Sunglasses (non-prescription Including Photosensitive)

Leading manufacturers include Roseburg SA, D&K Stores, Inc. and Custom Optical Frames, Inc..

646
Total
646
Cleared
92d
Avg days
1979
Since
646 devices
25–48 of 646
Cleared Jun 24, 1997
CEBE
K971644
Suunto USA
Ophthalmic · 50d
Cleared Jun 24, 1997
SUNGLASSES (NON-PRESCRIPTION)
K972014
Tamfort, Ltd.
Ophthalmic · 25d
Cleared Jun 24, 1997
RIVIERA SUNGLASS4ES
K972194
Riviera Optical Co., Ltd.
Ophthalmic · 14d
Cleared Jun 13, 1997
SUNGLASSES (FRAME,CELLULOSE PROPINATE, LENS, ACRYLIC)
K971087
W.J. Byrnes & Co. of Los Angeles, Inc.
Ophthalmic · 80d
Cleared Jun 13, 1997
SUNGLASSES (NON-PRESCRIPTION)
K971707
Niko Sunglasses Corp.
Ophthalmic · 38d
Cleared Jun 13, 1997
OPTIM-EYES 450
K971875
Taylor/Fox Enterprises, LLC
Ophthalmic · 24d
Cleared Jun 05, 1997
GLARE WARE
K970816
Ergovision, Inc.
Ophthalmic · 91d
Cleared Jun 04, 1997
DUQIAO
K971551
Duqiao Glasses (Group) Co. , Ltd.
Ophthalmic · 37d
Cleared May 29, 1997
PATHFINDER SUNGLASSES
K971495
Coil
Ophthalmic · 35d
Cleared May 13, 1997
AURORA SUNGLASSES,SKI GOGGLES AND PROTECTIVE/SAFTEY GOGGLES
K970699
Yeong Jiuh Corp.
Ophthalmic · 77d
Cleared May 13, 1997
SUNGLASSES
K971412
Team Chien Industrial Co., Ltd.
Ophthalmic · 27d
Cleared May 09, 1997
UNIKA
K971327
Eyewear Partners Co.
Ophthalmic · 29d
Cleared May 06, 1997
EVEREST SUNGLASSES
K970315
Ycc International Corp.
Ophthalmic · 99d
Cleared May 06, 1997
LAXIMA INTERNATIONAL LIMITED SUNGLASSES
K970454
Laxima Intl., Ltd.
Ophthalmic · 90d
Cleared May 06, 1997
HWA MAO OPTICAL SUNGLASSES (NON-PRESCRIPTION)
K970476
Hwa Mao Optical Co., Ltd.
Ophthalmic · 88d
Cleared May 06, 1997
SOLAR SPECS
K970759
Morris Rosenbloom & Co., Inc.
Ophthalmic · 64d
Cleared May 06, 1997
CUSTOM OPTICAL SUNGLASS FRAMES
K970895
Custom Optical Frames, Inc.
Ophthalmic · 56d
Cleared May 06, 1997
BARAKKA, INFERNO, STERLING, AND/OR ONE
K970944
Sentinal Importing Corp.
Ophthalmic · 54d
Cleared May 06, 1997
CLASSIC MATCH
K971104
Delagar Division Belcam, Inc.
Ophthalmic · 41d
Cleared May 06, 1997
GOLDEN STATE IMPORTS INTERNATIONAL, INC./ COLEMAN
K971249
Andrew G. Halpern
Ophthalmic · 33d
Cleared May 06, 1997
ARROW COMPANY
K971326
Excel Eyewear Corp.
Ophthalmic · 26d
Cleared Mar 31, 1997
STYLE EYES OPTICS
K970744
Anti-Ray, Inc.
Ophthalmic · 31d
Cleared Mar 25, 1997
VICTORY EYEWEAR CO
K970538
Victory Eyewear Co., Ltd.
Ophthalmic · 41d
Cleared Mar 19, 1997
DAKOTA SMITH, NICOLE MILLER SUNGLASSES
K965125
California Design Studio, Inc.
Ophthalmic · 86d