510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K221759Substantially Equivalent

Cornisol

Aurolab, Veerapanjan, Madurai, IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K221759 is the FDA 510(k) clearance record for Cornisol, cleared for Aurolab on under FDA product code LYX (Media, Corneal Storage). FDA records list 4 510(k) clearances for Aurolab, from to . As of , FDA records show no recalls naming K221759.

Clearance record

Decision date
Received
(110 days to decision)
Product code
LYX Media, Corneal Storage
Device class
Unclassified
Review panel
Unknown
Applicant
Aurolab #1, Sivagangai Main Rd., Veerapanjan, Madurai, IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LYX

Trailing 12 months

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

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