510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K063304Substantially Equivalent

Life4c

Numedis, Inc., Monson MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K063304 is the FDA 510(k) clearance record for LIFE4C, cleared for Numedis, Inc. on under FDA product code LYX (Media, Corneal Storage). FDA records list one 510(k) clearance for Numedis, Inc. As of , FDA records show no recalls naming K063304.

Clearance record

Decision date
Received
(415 days to decision)
Product code
LYX Media, Corneal Storage
Device class
Unclassified
Review panel
Unknown
Applicant
Numedis, Inc. 188 Bumstead Rd., Monson MA
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