Cleared Traditional

K982168 - SOLO-CARE BRAND MULTI-PURPOSE SOLUTION

K982168 is an FDA 510(k) clearance for SOLO-CARE BRAND MULTI-PURPOSE 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 151-day FDA review.

K982168 · Ciba Vision Corporation · Ophthalmic device
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Nov 1998
Decision
151d
Days
Class 2
Risk

K982168 is an FDA 510(k) clearance for the SOLO-CARE BRAND 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 November 17, 1998 after a review of 151 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 - K982168

510(k) Number K982168 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1998
Decision Date November 17, 1998
Days to Decision 151 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
41d slower than avg
Panel avg: 110d · This submission: 151d
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 K982168.
OPTI-ONE MULTI-PURPOSE SOLUTION
K983973 · Alcon Laboratories · Dec 1998
ULTRACARE NEUTRALIZING TABLETS
K984383 · Allergan, Inc. · Dec 1998
COMPLETE BRAND LUBRICATING AND REWETTING DROPS
K983150 · Allergan, Inc. · Nov 1998
BAUSCH & LOMB RENU MULTI-PURPOSE SOLUTION
K982775 · Bausch & Lomb, Inc. · Nov 1998
COMPLETE BRAND MULTI-PURPOSE SOLUTION, COMPLETE BRAND LUBRICATING AND REWETTING DROPS
K981168 · Allergan, Inc. · Sep 1998
LIQUID ENZYME ID 90133
K981561 · Alcon Laboratories · Jul 1998