Cleared Abbreviated

K143434 - One Series ULTRA Cartridge, The UNFOLDER Platinum 1 Series

K143434 is an FDA 510(k) clearance for One Series ULTRA Cartridge, manufactured by Abbott Medical Optics, Inc.. The device is a Class 1 Ophthalmic device with product code MSS cleared through the Abbreviated 510(k) pathway after a 156-day FDA review.

K143434 · Abbott Medical Optics, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2015
Decision
156d
Days
Class 1
Risk

K143434 is an FDA 510(k) clearance for the One Series ULTRA Cartridge, The UNFOLDER Platinum 1 Series. Classified as Folders And Injectors, Intraocular Lens (iol) (product code MSS), Class I - General Controls.

Submitted by Abbott Medical Optics, Inc. (Santa Ana, US). The FDA issued a Cleared decision on May 6, 2015 after a review of 156 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Abbott Medical Optics, Inc. devices

FDA 510(k) Submission Details - K143434

510(k) Number K143434 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 2014
Decision Date May 06, 2015
Days to Decision 156 days
Submission Type Abbreviated
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
46d slower than avg
Panel avg: 110d · This submission: 156d
Pathway characteristics
Standards-based clearance path.

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

Johnson & Johnson Surgical Vision, Inc.
Nooshin Azizi

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 61
Devices cleared under the same product code (MSS) and FDA review panel - the closest regulatory comparables to K143434.
Lenstec LC Injection system
K161776 · Lenstec, Inc. · Nov 2016
Easy-Load Lens Delivery System
K161012 · Bausch and Lomb, Inc., · Jul 2016
Bausch + Lomb Injector System
K151102 · Bausch & Lomb, Inc. · May 2015
LIOLI IOL DELIVERY SYSTEM
K142056 · Ast Products, Inc. · Apr 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