Cleared Traditional

K031957 - MODIFICATION TO KARATS MULTI-PURPOSE SOLUTION

K031957 is an FDA 510(k) clearance for MODIFICATION TO KARATS MULTI-PURPOSE SO..., manufactured by Ciba Vision Corporation. The device is a Class 2 Ophthalmic device with product code LPN cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K031957 · Ciba Vision Corporation · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2003
Decision
50d
Days
Class 2
Risk

K031957 is an FDA 510(k) clearance for the MODIFICATION TO KARATS MULTI-PURPOSE SOLUTION. Classified as Accessories, Soft Lens Products (product code LPN), Class II - Special Controls.

Submitted by Ciba Vision Corporation (Duluth, US). The FDA issued a Cleared decision on August 14, 2003 after a review of 50 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ciba Vision Corporation devices

FDA 510(k) Submission Details - K031957

510(k) Number K031957 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 2003
Decision Date August 14, 2003
Days to Decision 50 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
60d faster than avg
Panel avg: 110d · This submission: 50d
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 75
Devices cleared under the same product code (LPN) and FDA review panel - the closest regulatory comparables to K031957.
AQUIFY MULTI-PURPOSE SOLUTION
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AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION
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SOLO-CARE PLUS MULTIPURPOSE SOLUTION
K031522 · Ciba Vision Corporation · Jun 2003
KARATS MULTIPURPOSE SOLUTION
K021635 · Ciba Vision Corporation · Oct 2002