510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K863651Substantially Equivalent

Polarex and Polarex Mld

Selex, Inc., Doraville GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K863651 is the FDA 510(k) clearance record for POLAREX AND POLAREX MLD, a class I device, cleared for Selex, Inc. on under FDA product code HQY (Sunglasses (Non-Prescription Including Photosensitive)). FDA records list one 510(k) clearance for Selex, Inc. As of , FDA records show no recalls naming K863651.

Clearance record

Decision date
Received
(22 days to decision)
Product code
HQY Sunglasses (Non-Prescription Including Photosensitive)
Regulation
21 CFR 886.5850
Device class
Class I
Review panel
Ophthalmic
Applicant
Selex, Inc. P. O. Box 48505, Doraville GA
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