Cleared Traditional

K991403 - SOLO-CARE BRAND MULTI-PURPOSE SOLUTION

K991403 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 85-day FDA review.

K991403 · Ciba Vision Corporation · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1999
Decision
85d
Days
Class 2
Risk

K991403 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 July 16, 1999 after a review of 85 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

Submission Details

510(k) Number K991403 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1999
Decision Date July 16, 1999
Days to Decision 85 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
25d faster than avg
Panel avg: 110d · This submission: 85d
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 K991403.
RENU MULTIPLUS MULTI-PURPOSE DISINFECTING SOLUTION
K002823 · Bausch & Lomb, Inc. · Oct 2000
RENU MULTIPLUS MULTI-PURPOSE SOLUTION
K001539 · Bausch & Lomb, Inc. · Jul 2000
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