Cleared Abbreviated

VITRECTOMY CUTTER AND ACCESSORIES (K081681) - FDA 510(k) Clearance

Class II Ophthalmic device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K081681 · Advanced Medical Optics, Inc. · Ophthalmic device
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Oct 2008
Decision
113d
Days
Class 2
Risk

K081681 is an FDA 510(k) clearance for the VITRECTOMY CUTTER AND ACCESSORIES. Classified as Vitrectomy, Instrument Cutter (product code MLZ), Class II - Special Controls.

Submitted by Advanced Medical Optics, Inc. (Santa Ana, US). The FDA issued a Cleared decision on October 8, 2008 after a review of 113 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4150 - 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 Advanced Medical Optics, Inc. devices

Submission Details

510(k) Number K081681 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2008
Decision Date October 08, 2008
Days to Decision 113 days
Submission Type Abbreviated
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 110d · This submission: 113d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code MLZ Vitrectomy, Instrument Cutter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4150
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.