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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ophthalmic Syringe
510(k) Number K243322
Device Name Altaviz Intravitreal Syringe
Applicant
Altaviz, LLC
13766 Alton Pkwy., Suite 143
Irvine,  CA  92618
Applicant Contact James Lescoulie
Correspondent
Allied Regulatory Consulting
1540 Keller Pkwy., Suite 108 #170
Keller,  TX  76248
Correspondent Contact Sean Griffin
Regulation Number880.5860
Classification Product Code
QLY  
Subsequent Product Code
FMF  
Date Received10/23/2024
Decision Date 05/09/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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