Cleared Abbreviated

K040839 - COMPLETE BLINK-N-CLEAN LENS DROPS

K040839 is an FDA 510(k) clearance for COMPLETE BLINK-N-CLEAN LENS DROPS, manufactured by Advanced Medical Optics, Inc.. The device is a Class 2 Ophthalmic device with product code MRC cleared through the Abbreviated 510(k) pathway after a 202-day FDA review.

K040839 · Advanced Medical Optics, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2004
Decision
202d
Days
Class 2
Risk

K040839 is an FDA 510(k) clearance for the COMPLETE BLINK-N-CLEAN LENS DROPS. Classified as Products, Contact Lens Care, Rigid Gas Permeable (product code MRC), Class II - Special Controls.

Submitted by Advanced Medical Optics, Inc. (Santa Ana, US). The FDA issued a Cleared decision on October 19, 2004 after a review of 202 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5918 - 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

FDA 510(k) Submission Details - K040839

510(k) Number K040839 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2004
Decision Date October 19, 2004
Days to Decision 202 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
92d slower than avg
Panel avg: 110d · This submission: 202d
Pathway characteristics
Standards-based clearance path.

MRC Device Classification - Class 2, Special Controls

Product Code MRC Products, Contact Lens Care, Rigid Gas Permeable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5918
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.

Regulatory Peers - MRC Products, Contact Lens Care, Rigid Gas Permeable

All 23
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