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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Media, Corneal Storage
510(k) Number K251320
Device Name XTRA4
Applicant
Al.Chi.Mi.A. S.R.L
Viale Austria, 14
Ponte San Nicolò,  IT 35020
Applicant Contact Niccolò Bufo
Correspondent
Allied Regulatory Consulting
1540 Keller Pkwy., Suite 108 #170
Keller,  TX  76248
Correspondent Contact Sean Griffin
Classification Product Code
LYX  
Date Received04/29/2025
Decision Date 09/11/2025
Decision Substantially Equivalent (SESE)
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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