Cleared Traditional

K142056 - LIOLI IOL DELIVERY SYSTEM

K142056 is an FDA 510(k) clearance for LIOLI IOL DELIVERY SYSTEM, manufactured by Ast Products, Inc.. The device is a Class 1 Ophthalmic device with 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

FDA 510(k) Submission Details - K142056

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
144d slower than avg
Panel avg: 110d · This submission: 254d
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 Consultant

Regulatory Doctor
DAVID LIM

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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

All 42
Devices cleared under the same product code (MSS) and FDA review panel - the closest regulatory comparables to K142056.
Easy-Load Lens Delivery System
K161012 · Bausch and Lomb, Inc., · Jul 2016
Bausch + Lomb Injector System
K151102 · Bausch & Lomb, Inc. · May 2015
One Series ULTRA Cartridge, The UNFOLDER Platinum 1 Series
K143434 · Abbott Medical Optics, Inc. · May 2015
RaySert PLUS Injector, Single Use Soft Tipped Disposable Injector
K143307 · Rayner Intraocular Lenses , Ltd. · Dec 2014
RAYSERT PLUS INJECTOR
K141091 · Rayner Intraocular Lenses , Ltd. · May 2014
SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, RAYSERT SINGLE USE SOFT TIPPED SMALL INCISION DISPOSABLE INJECTOR
K132002 · Rayner Intraocular Lenses , Ltd. · Mar 2014