510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K911766Substantially Equivalent

Sunglasses-Nonprescription Including Photosen.

Gall'S, Inc., Lexington KY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K911766 is the FDA 510(k) clearance record for SUNGLASSES-NONPRESCRIPTION INCLUDING PHOTOSEN., a class I device, cleared for Gall'S, Inc. on under FDA product code HQY (Sunglasses (Non-Prescription Including Photosensitive)). FDA records list one 510(k) clearance for Gall'S, Inc. As of , FDA records show no recalls naming K911766.

Clearance record

Decision date
Received
(33 days to decision)
Product code
HQY Sunglasses (Non-Prescription Including Photosensitive)
Regulation
21 CFR 886.5850
Device class
Class I
Review panel
Ophthalmic
Applicant
Gall'S, Inc. 2470 Palumbo Dr., Lexington KY
510(k) summary
Statement
Third party review
No

Clearances, product code HQY

Trailing 12 months

FDA records hold no clearances under product code HQY in the trailing twelve months.

FDA records show no clearances under product code HQY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HQY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260