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510(k) K221872

ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System by Nova Eye Inc. (Business Name Nova Eye Medical) — Product Code MPA

K221872 is an FDA 510(k) premarket notification submitted by Nova Eye Inc. (Business Name Nova Eye Medical) for the device "ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System". The FDA issued a decision of Substantially Equivalent on March 30, 2023. The device falls under product code MPA (Endoilluminator), a Class II device regulated under 21 CFR 876.1500.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 2023
Date Received
June 28, 2022
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoilluminator
Device Class
Class II
Regulation Number
876.1500
Review Panel
OP
Submission Type

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FDA data resources