Cleared Traditional

K021635 - KARATS MULTIPURPOSE SOLUTION

K021635 is an FDA 510(k) clearance for KARATS MULTIPURPOSE SOLUTION, 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 164-day FDA review.

K021635 · Ciba Vision Corporation · Ophthalmic device
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Oct 2002
Decision
164d
Days
Class 2
Risk

K021635 is an FDA 510(k) clearance for the KARATS MULTIPURPOSE 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 October 28, 2002 after a review of 164 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Ciba Vision Corporation devices

FDA 510(k) Submission Details - K021635

510(k) Number K021635 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2002
Decision Date October 28, 2002
Days to Decision 164 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
54d slower than avg
Panel avg: 110d · This submission: 164d
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 K021635.
MODIFICATION TO KARATS MULTI-PURPOSE SOLUTION
K031957 · Ciba Vision Corporation · Aug 2003
AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION
K031521 · Ciba Vision Corporation · Jun 2003
SOLO-CARE PLUS MULTIPURPOSE SOLUTION
K031522 · Ciba Vision Corporation · Jun 2003
COMPLETE BRAND MULTI-PURPOSE SOLUTION
K014202 · Allergan, Inc. · Feb 2002
COMPLETE BRAND MULTI-PURPOSE SOLUTION
K013479 · Allergan, Inc. · Feb 2002
SOLO-CARE PLUS MULTIPURPOSE SOLUTION
K012731 · Ciba Vision Corporation · Dec 2001