Cleared Traditional

K000148 - RGP MULTI-PURPOSE SOLUTION ID 100136

K000148 is the FDA 510(k) clearance for RGP MULTI-PURPOSE SOLUTION ID 100136 by Alcon Laboratories. It is a Class 2 Ophthalmic device (product code MRC) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K000148 · Alcon Laboratories · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2000
Decision
84d
Days
Class 2
Risk

K000148 is an FDA 510(k) clearance for the RGP MULTI-PURPOSE SOLUTION ID 100136. Classified as Products, Contact Lens Care, Rigid Gas Permeable (product code MRC), Class II - Special Controls.

Submitted by Alcon Laboratories (Fort Worth, US). The FDA issued a Cleared decision on April 11, 2000 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5918 - 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 Alcon Laboratories devices

Submission Details

510(k) Number K000148 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 2000
Decision Date April 11, 2000
Days to Decision 84 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
26d faster than avg
Panel avg: 110d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MRC Products, Contact Lens Care, Rigid Gas Permeable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5918
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 - MRC Products, Contact Lens Care, Rigid Gas Permeable

All 12
Devices cleared under the same product code (MRC) and FDA review panel - the closest regulatory comparables to K000148.
AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION
K023455 · Ciba Vision Corporation · Feb 2003
AQUIFY LENS COMFORT DROPS
K013204 · Ciba Vision Corporation · Apr 2002
SOLO-CARE BRAND HARD SOLUTION
K000607 · Ciba Vision Corporation · May 2000
SOLO-CARE BRAND HARD SOLUTION
K993949 · Ciba Vision Corporation · Jan 2000
SOLO-CARE BRAND MULTI-PURPOSE SOLUTION
K983291 · Ciba Vision Corporation · Nov 1998