Cleared Abbreviated

ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System

K221872 · Nova Eye Inc. (Business Name Nova Eye Medical) · Ophthalmic

Mar 2023

Decision

275d

Days

Class 2

Risk

About This 510(k) Submission

K221872 is an FDA 510(k) clearance for the ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System, a Endoilluminator (Class II — Special Controls, product code MPA), submitted by Nova Eye Inc. (Business Name Nova Eye Medical) (Fremont, US). The FDA issued a Cleared decision on March 30, 2023, 275 days after receiving the submission on June 28, 2022. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K221872 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 28, 2022
Decision Date	March 30, 2023
Days to Decision	275 days
Submission Type	Abbreviated
Review Panel	Ophthalmic (OP)
Summary	Summary PDF