FDA.reportPublic FDA data

510(k) K251320

Device
XTRA4
Applicant
Al.Chi.Mi.A. S.R.L
510(k) number
K251320
Product code
LYX
Decision
Substantially Equivalent (SESE)
Decision date
2025-09-11
Date received
2025-04-29
Classification name
Media, Corneal Storage
Medical specialty
Unknown
Review panel
Unknown
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Niccolò Bufo
Address
Viale Austria, 14 Ponte San Nicolò IT 35020 35020

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LYX#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K221759CornisolAurolab2022-10-05
K211786Independent Corneal Viewing Chamber (IVC-21)Bausch + Lomb, Incorporated2021-12-03
K162013Eusol-CAl.Chi.Mi.A. S.R.L2016-09-15
K151061Cornea ColdEurobio2015-08-06
K063304LIFE4CNumedis, Inc.2007-12-21
K063617EUSOL-CAl.Chi.Mi.A2007-02-08
K032422EUSOL-CAl.Chi.Mi.A2003-12-15
K954548THE CHEN MEDIUMChen Ophthalmic Laboratories1996-05-20
K924165OPTISOL-GS CORNEAL STORAGE MEDIAChiron Intraoptics1992-10-06
K921728DEXSOL CORNEAL STORAGE MEDIA CONTAINER, MODIFIEDChiron Intraoptics1992-06-09
K921729OPTISOL CORNEAL STORAGE MEDIA CONTAINER/MODIFIEDChiron Intraoptics1992-06-09
K894162OPTISOLChiron Ophthalmics1990-01-12
K883854DEXSOLNorthern Scientific, Inc.1988-11-16
K870249MCCAREY-KAUFMAN CORNEAL STORAGE MEDIUMBioclinical Laboratory Services, Inc.1987-04-06
K870250MODIFIED MCCAREY-KAUFMAN CORNEAL STORAGE MEDIUMBioclinical Laboratory Services, Inc.1987-04-06