Cleared Traditional

K081545 - ONE SERIES ULTRA CARTRIDGE, MODEL 1VIPR30

K081545 is an FDA 510(k) clearance for ONE SERIES ULTRA CARTRIDGE, manufactured by Advanced Medical Optics, Inc.. The device is a Class 1 Ophthalmic device with product code MSS cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K081545 · Advanced Medical Optics, Inc. · Ophthalmic device
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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

FDA 510(k) Submission Details - K081545

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.

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

All 25
Devices cleared under the same product code (MSS) and FDA review panel - the closest regulatory comparables to K081545.
MONARCH III IOL DELIVERY SYSTEM, MONARCH III C CARTRIDGE, MONARCH III HANDPIECE (H4)
K112977 · Alcon Research, Ltd. · Mar 2012
EPIPHANY INJECTION SYSTEM
K090161 · Staar Surgical Co. · Jun 2009
CRYSTALSERT CRYSTALENS DELIVERY SYSTEM
K082944 · Bausch & Lomb, Inc. · Oct 2008
MICROSTAAR INDIGO INJECTOR FOAM TIP SYSTEM
K073586 · Staar Surgical Co. · Mar 2008
MICROSTAAR MSI INJECTOR FOAM TIP SYSTEM
K073591 · Staar Surgical Co. · Mar 2008
MONARCH II IOL DELIVERY SYSTEM
K003768 · Alcon Research, Ltd. · Jan 2001