Cleared Traditional

LIOLI IOL DELIVERY SYSTEM (K142056) - FDA 510(k) Clearance

Class I Ophthalmic device.

K142056 · Ast Products, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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 61
Devices cleared under the same product code (MSS) and FDA review panel - the closest regulatory comparables to K142056.
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Accuject Refra Injector AR2900
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RxSight® Insertion Device (63002)
K231838 · Rxsight, Inc. · Aug 2023
RxSight Insertion Device
K231466 · Rxsight, Inc. · Jun 2023
CLAREON MONARCH IV IOL Delivery System
K212039 · Alcon Laboratories, Inc. · Aug 2021