Cleared Traditional

K142056 - LIOLI IOL DELIVERY SYSTEM

K142056 is the FDA 510(k) clearance for LIOLI IOL DELIVERY SYSTEM by Ast Products, Inc.. It is a Class 1 Ophthalmic device (product code MSS) cleared through the Traditional 510(k) pathway after a 254-day FDA review.

K142056 · Ast Products, Inc. · Ophthalmic device
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Apr 2015
Decision
254d
Days
Class 1
Risk

K142056 is an FDA 510(k) clearance for the LIOLI IOL DELIVERY SYSTEM. Classified as Folders And Injectors, Intraocular Lens (iol) (product code MSS), Class I - General Controls.

Submitted by Ast Products, Inc. (Billerica, US). The FDA issued a Cleared decision on April 9, 2015 after a review of 254 days - an extended review cycle.

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 Ast Products, Inc. devices

Submission Details

510(k) Number K142056 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2014
Decision Date April 09, 2015
Days to Decision 254 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
144d slower than avg
Panel avg: 110d · This submission: 254d
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 16
Devices cleared under the same product code (MSS) and FDA review panel - the closest regulatory comparables to K142056.
RxSight Insertion Device
K181401 · Rxsight, Inc. · Jul 2018
Crystalsert Lens Delivery System
K173480 · Bausch & Lomb, Inc. · Dec 2017
Bausch + Lomb Injector System
K151102 · Bausch & Lomb, Inc. · May 2015
BAUSCH & LOMB IOL INJECTOR
K113852 · Bausch & Lomb, Inc. · Sep 2012
CRYSTALSERT CRYSTALENS DELIVERY SYSTEM
K082944 · Bausch & Lomb, Inc. · Oct 2008