510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K853043Substantially Equivalent

700-123 Eye Shade

Health Saver Products, On Canada L3m 4gi, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K853043 is the FDA 510(k) clearance record for 700-123 EYE SHADE, a class I device, cleared for Health Saver Products on under FDA product code HQY (Sunglasses (Non-Prescription Including Photosensitive)). FDA records list 2 510(k) clearances for Health Saver Products, from to . As of , FDA records show no recalls naming K853043.

Clearance record

Decision date
Received
(147 days to decision)
Product code
HQY Sunglasses (Non-Prescription Including Photosensitive)
Regulation
21 CFR 886.5850
Device class
Class I
Review panel
Ophthalmic
Applicant
Health Saver Products P.O. Box 39, On Canada L3m 4gi, CA
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