510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K941084Substantially Equivalent

Sunglasses

Blue Gem Sunglasses, Inc., Carpinteria CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K941084 is the FDA 510(k) clearance record for SUNGLASSES, a class I device, cleared for Blue Gem Sunglasses, Inc. on under FDA product code HQY (Sunglasses (Non-Prescription Including Photosensitive)). FDA records list one 510(k) clearance for Blue Gem Sunglasses, Inc. As of , FDA records show no recalls naming K941084.

Clearance record

Decision date
Received
(524 days to decision)
Product code
HQY Sunglasses (Non-Prescription Including Photosensitive)
Regulation
21 CFR 886.5850
Device class
Class I
Review panel
Ophthalmic
Applicant
Blue Gem Sunglasses, Inc. 6381 Unit B, Carpinteria CA
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