Eusol-C

FDA 510(k) K063617 · Al.Chi.Mi.A

Substantially Equivalent

510(k) numberK063617

Submission

Device name
Eusol-C
Applicant
Al.Chi.Mi.A
Hasbrouck Heights, NJ, US
Received
December 5, 2006
Decision date
February 8, 2007
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LYX – Media, Corneal Storage
Device class
Unclassified

Other 510(k)s with product code LYX

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K211786Independent Corneal Viewing Chamber (IVC-21)LYX · Traditional Bausch + Lomb, Incorporated12/03/2021SE
K162013Eusol-CLYX · Special Al.Chi.Mi.A. S.R.L09/15/2016SE
K151061Cornea ColdLYX · Traditional Eurobio08/06/2015SE
K063304LIFE4CLYX · Traditional Numedis, Inc.12/21/2007SE
K032422Eusol-CLYX · Traditional Al.Chi.Mi.A12/15/2003SE
K954548The Chen MediumLYX · Traditional Chen Ophthalmic Laboratories05/20/1996SE
K924165Optisol-Gs Corneal Storage MediaLYX · Traditional Chiron Intraoptics10/06/1992SE
K921729Optisol Corneal Storage Media Container/ModifiedLYX · Traditional Chiron Intraoptics06/09/1992SE

More from Chiron Intraoptics

510(k)DeviceDecision
K032422Eusol-CLYX · Traditional 12/15/2003SE

Questions and answers

When was Eusol-C cleared by the FDA?

Eusol-C (K063617) received a 510(k) decision of Substantially Equivalent on February 8, 2007, 65 days after the submission was received.

What is the product code of K063617?

The FDA product code is LYX – Media, Corneal Storage, a Unclassified device.