Cleared Traditional

ONE SERIES ULTRA CARTRIDGE, MODEL 1VIPR30 (K081545) - FDA 510(k) Clearance

Class I Ophthalmic device.

K081545 · Advanced Medical Optics, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2008
Decision
122d
Days
Class 1
Risk

K081545 is an FDA 510(k) clearance for the ONE SERIES ULTRA CARTRIDGE, MODEL 1VIPR30. Classified as Folders And Injectors, Intraocular Lens (iol) (product code MSS), Class I - General Controls.

Submitted by Advanced Medical Optics, Inc. (Santa Ana, US). The FDA issued a Cleared decision on October 2, 2008 after a review of 122 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.

View all Advanced Medical Optics, Inc. devices

Submission Details

510(k) Number K081545 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2008
Decision Date October 02, 2008
Days to Decision 122 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
12d slower than avg
Panel avg: 110d · This submission: 122d
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 K081545.
ACCUJECT Injector Set 2.1-1P (LP604590)
K252540 · Medicel AG · Sep 2025
EyeGility™ Inserter for Preloaded enVista IOLs
K242389 · Bausch & Lomb, Incorporated · Oct 2024
Accuject Refra Injector AR2900
K231106 · Medicel AG · Sep 2023
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