Cleared Traditional

K123888 - Z CARTRIDGE IOL DELIVERY SYSTEM

K123888 is an FDA 510(k) clearance for Z CARTRIDGE IOL DELIVERY SYSTEM, manufactured by Aaren Scientific, Inc.. The device is a Class 1 Ophthalmic device with product code MSS cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K123888 · Aaren Scientific, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K123888

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 110d · This submission: 118d
Pathway characteristics
Predicate-based equivalence.

MSS Device Classification - Class 1, General Controls

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 62
Devices cleared under the same product code (MSS) and FDA review panel - the closest regulatory comparables to K123888.
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K112977 · Alcon Research, Ltd. · Mar 2012
MONARCH III IOL DELIVERY SYSTEM
K101774 · Alcon Manufacturing, Ltd. · Oct 2011
K123888 · Z CARTRIDGE IOL DELIVERY SYSTEM
Download PDF FDA Summary Aaren Scientific, Inc.