Cleared Traditional

K253468 - Nova Eye iTrack™ 250A Canaloplasty Microcatheter (iTrack™ 250A)

K253468 is an FDA 510(k) clearance for Nova Eye iTrack 250A Canaloplasty Micro..., manufactured by Nova Eye, Inc.. The device is a Class 2 Ophthalmic device with product code MPA cleared through the Traditional 510(k) pathway after a 305-day FDA review.

K253468 · Nova Eye, Inc. · Ophthalmic device
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Aug 2026
Decision
305d
Days
Class 2
Risk

K253468 is an FDA 510(k) clearance for the Nova Eye iTrack™ 250A Canaloplasty Microcatheter (iTrack™ 250A). Classified as Endoilluminator (product code MPA), Class II - Special Controls.

Submitted by Nova Eye, Inc. (Fremont, US). The FDA issued a Cleared decision on August 10, 2026 after a review of 305 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 876.1500 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Nova Eye, Inc. devices

FDA 510(k) Submission Details - K253468

510(k) Number K253468 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 2025
Decision Date August 10, 2026
Days to Decision 305 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
195d slower than avg
Panel avg: 110d · This submission: 305d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MPA Device Classification - Class 2, Special Controls

Product Code MPA Endoilluminator
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - MPA Endoilluminator

All 31
Devices cleared under the same product code (MPA) and FDA review panel - the closest regulatory comparables to K253468.
Alcon 27GA Chandelier (8065000252)
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Midfield Light Pipe, 23ga (3269.M06-00)
K233653 · Peregrine Surgical, LLC · Aug 2024
ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System
K221872 · Nova Eye Inc. (Business Name Nova Eye Medical) · Mar 2023
Nam illumination probe with chopper
K202670 · Oculight , Ltd. · Aug 2021
23ga Chandelier Illuminator, 25ga Chandelier Illuminator
K151604 · Peregrine Surgical , Ltd. · Sep 2015
Synergetics PHOTON EX
K143123 · Synergetics · Feb 2015