Cleared Traditional

K123888 - Z CARTRIDGE IOL DELIVERY SYSTEM (FDA 510(k) Clearance)

Class I Ophthalmic device.

K123888 · Aaren Scientific, Inc. · Ophthalmic device
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Apr 2013
Decision
118d
Days
Class 1
Risk

K123888 is an FDA 510(k) clearance for the Z CARTRIDGE IOL DELIVERY SYSTEM. Classified as Folders And Injectors, Intraocular Lens (iol) (product code MSS), Class I - General Controls.

Submitted by Aaren Scientific, Inc. (Ontario, US). The FDA issued a Cleared decision on April 15, 2013 after a review of 118 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4300 - 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. Standard predicate reliance. 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 Aaren Scientific, Inc. devices

Submission Details

510(k) Number K123888 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2012
Decision Date April 15, 2013
Days to Decision 118 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 110d · This submission: 118d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MSS Folders And Injectors, Intraocular Lens (iol)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4300
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - MSS Folders And Injectors, Intraocular Lens (iol)

All 61
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