Cleared Traditional

K093254 - AMO BRAND MULTI-PURPOSE DISINFECTING SOLUTION (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K093254 · Abbott Medical Optics, Inc. · Ophthalmic device
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Sep 2010
Decision
334d
Days
Class 2
Risk

K093254 is an FDA 510(k) clearance for the AMO BRAND MULTI-PURPOSE DISINFECTING SOLUTION. Classified as Accessories, Soft Lens Products (product code LPN), Class II - Special Controls.

Submitted by Abbott Medical Optics, Inc. (Santa Ana, US). The FDA issued a Cleared decision on September 15, 2010 after a review of 334 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5928 - 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. Elevated predicate reliance profile. 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 Abbott Medical Optics, Inc. devices

Submission Details

510(k) Number K093254 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 2009
Decision Date September 15, 2010
Days to Decision 334 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
224d slower than avg
Panel avg: 110d · This submission: 334d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LPN Accessories, Soft Lens Products
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5928
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 - LPN Accessories, Soft Lens Products

All 119
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