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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoilluminator
510(k) Number K253468
Device Name Nova Eye iTrack™ 250A Canaloplasty Microcatheter (iTrack™ 250A)
Applicant
Nova Eye, Inc.
41316 Christy St.
Fremont,  CA  94538
Applicant Contact Don Watton
Correspondent
Nova Eye, Inc.
41316 Christy St.
Fremont,  CA  94538
Correspondent Contact Don Watton
Regulation Number876.1500
Classification Product Code
MPA  
Subsequent Product Code
HMX  
Date Received10/09/2025
Decision Date 08/10/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
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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