Cleared Traditional

K093254 - AMO BRAND MULTI-PURPOSE DISINFECTING SOLUTION

K093254 is an FDA 510(k) clearance for AMO BRAND MULTI-PURPOSE DISINFECTING SO..., manufactured by Abbott Medical Optics, Inc.. The device is a Class 2 Ophthalmic device with product code LPN cleared through the Traditional 510(k) pathway after a 334-day FDA review.

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

FDA 510(k) Submission Details - K093254

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
Combination Product No
PCCP Authorized No
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.

LPN Device Classification - Class 2, Special Controls

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 104
Devices cleared under the same product code (LPN) and FDA review panel - the closest regulatory comparables to K093254.
EYE-CEPT STERILE SALINE SOLUTION
K110221 · Optics Laboratory, Inc. · Nov 2011
ALCON MULTI-PIRPOSE DISINFECTING SOLUTION
K102860 · Alcon Research, Ltd. · May 2011
STERILE SALINE SOLUTION
K102165 · Cachet Pharmaceuticals Pvt. , Ltd. · Jan 2011
STERILE SALINE SOLUTION
K093367 · Cachet Pharmaceuticals Pvt. , Ltd. · Sep 2010
REFRESH OPTIVE LENS COMFORT REWETTING DROPS
K083812 · Allergan, Inc. · Jul 2009
ALCON MULTI-PURPOSE SOLUTION
K071236 · Alcon, Inc. · Dec 2007