510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K852403Substantially Equivalent

Auralite II

Aura Lens Products, St. Cloud MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K852403 is the FDA 510(k) clearance record for AURALITE II, a class I device, cleared for Aura Lens Products on under FDA product code HQG (Lens, Spectacle, Non-Custom (Prescription)). FDA records list 2 510(k) clearances for Aura Lens Products, from to . As of , FDA records show no recalls naming K852403.

Clearance record

Decision date
Received
(75 days to decision)
Product code
HQG Lens, Spectacle, Non-Custom (Prescription)
Regulation
21 CFR 886.5844
Device class
Class I
Review panel
Ophthalmic
Applicant
Aura Lens Products P.O. Box 763, St. Cloud MN
Third party review
No

Clearances, product code HQG

Trailing 12 months

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

FDA records show no clearances under product code HQG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HQG, 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