Cleared Traditional

K982168 - SOLO-CARE BRAND MULTI-PURPOSE SOLUTION

K982168 is the FDA 510(k) clearance for SOLO-CARE BRAND MULTI-PURPOSE SOLUTION by Ciba Vision Corporation. It is a Class 2 Ophthalmic device (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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Optimized for regulatory review, auditing and printing
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

Submission Details

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
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.

Device Classification

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 24
Devices cleared under the same product code (LPN) and FDA review panel - the closest regulatory comparables to K982168.
BAUSCH & LOMB RENU 1 STEP DAILY PROTEIN REMOVER
K000247 · Bausch & Lomb, Inc. · Apr 2000
RENU MULTIPLUS MULTI-PURPOSE SOLUTION
K990422 · Bausch & Lomb, Inc. · Apr 1999
BAUSCH & LOMB RENU EFFERVESCENT ENZYMATIC CONTACT LENS CLEANER
K983225 · Bausch & Lomb, Inc. · Mar 1999
BAUSCH & LOMB RENU MULTI-PURPOSE SOLUTION
K982775 · Bausch & Lomb, Inc. · Nov 1998
RENU MULTIPLUS LUBRICATING & REWETTING DROPS
K980591 · Bausch & Lomb, Inc. · Jun 1998
RENU MULTIPLUS MULTI-PURPOSE SOLUTION
K974723 · Bausch & Lomb, Inc. · Mar 1998