510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K864543Substantially Equivalent

Sunglasses

Image of Hawaii, Waianae HI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864543 is the FDA 510(k) clearance record for SUNGLASSES, a class I device, cleared for Image of Hawaii on under FDA product code HQY (Sunglasses (Non-Prescription Including Photosensitive)). FDA records list one 510(k) clearance for Image of Hawaii. As of , FDA records show no recalls naming K864543.

Clearance record

Decision date
Received
(114 days to decision)
Product code
HQY Sunglasses (Non-Prescription Including Photosensitive)
Regulation
21 CFR 886.5850
Device class
Class I
Review panel
Ophthalmic
Applicant
Image of Hawaii 85-794 Farrington Hwy., Waianae HI
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