Cleared Abbreviated

K042562 - LENS PLUS REWETTING DROPS

K042562 is an FDA 510(k) clearance for LENS PLUS REWETTING DROPS, manufactured by Advanced Medical Optics, Inc.. The device is a Class 2 Ophthalmic device with product code LPN cleared through the Abbreviated 510(k) pathway after a 311-day FDA review.

K042562 · Advanced Medical Optics, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2005
Decision
311d
Days
Class 2
Risk

K042562 is an FDA 510(k) clearance for the LENS PLUS REWETTING DROPS. Classified as Accessories, Soft Lens Products (product code LPN), Class II - Special Controls.

Submitted by Advanced Medical Optics, Inc. (Santa Ana, US). The FDA issued a Cleared decision on July 29, 2005 after a review of 311 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 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 - K042562

510(k) Number K042562 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2004
Decision Date July 29, 2005
Days to Decision 311 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
201d slower than avg
Panel avg: 110d · This submission: 311d
Pathway characteristics
Standards-based clearance path.

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 80
Devices cleared under the same product code (LPN) and FDA review panel - the closest regulatory comparables to K042562.
REFRESH OPTIVE LENS COMFORT REWETTING DROPS
K083812 · Allergan, Inc. · Jul 2009
ALCON MULTI-PURPOSE DISINFECTING SOLUTION
K050729 · Alcon Research, Ltd. · Sep 2005
AQUIFY MULTIPURPOSE SOLUTION
K050250 · Ciba Vision Corporation · Aug 2005
AQUIFY LENS COMFORT DROPS
K042176 · Ciba Vision Corporation · Nov 2004
KARATS MULTIPURPOSE SOLUTION
K031753 · Ciba Vision Corporation · Oct 2004
AQUIFY MULTI-PURPOSE SOLUTION
K033608 · Ciba Vision Corporation · Feb 2004