Cleared Special

K001964 - OPTIMUM CLEANING, DISINFECTING AND STORAGE SOLUTION

K001964 is an FDA 510(k) clearance for OPTIMUM CLEANING, manufactured by Lobob Laboratories, Inc.. The device is a Class 2 Ophthalmic device with product code MRC cleared through the Special 510(k) pathway after a 21-day FDA review.

K001964 · Lobob Laboratories, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2000
Decision
21d
Days
Class 2
Risk

K001964 is an FDA 510(k) clearance for the OPTIMUM CLEANING, DISINFECTING AND STORAGE SOLUTION. Classified as Products, Contact Lens Care, Rigid Gas Permeable (product code MRC), Class II - Special Controls.

Submitted by Lobob Laboratories, Inc. (Washington, US). The FDA issued a Cleared decision on July 18, 2000 after a review of 21 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K001964

510(k) Number K001964 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2000
Decision Date July 18, 2000
Days to Decision 21 days
Submission Type Special
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
89d faster than avg
Panel avg: 110d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

MRC Device Classification - Class 2, Special Controls

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 32
Devices cleared under the same product code (MRC) and FDA review panel - the closest regulatory comparables to K001964.
DELTA PLUS MULTIACTION SOLUTION FOR RIGID GAS PERMEABLE CONTACT LENSES
K011456 · Sauflon Pharmaceuticals, Ltd. · Jul 2001
MENICON PROGENT REMOVER
K002140 · Menicon Co, Ltd. · Oct 2000
LIPIDURE REWETTING DROPS
K000975 · Nof Corp. · Sep 2000
OPTI-FREE SUPRACLENS DAILY POTEIN REMOVER / RGP MULTI-PURPOSE DISINFECTING SOLUTION ID 100136
K001235 · Alcon Universal, Ltd. · Jul 2000
OPTIMUM WETTING AND REWETTING DROP
K001428 · Lobob Laboratories, Inc. · May 2000
SOLO-CARE BRAND HARD SOLUTION
K000607 · Ciba Vision Corporation · May 2000
K001964 · OPTIMUM CLEANING, DISINFECTING AND STORAGE SOLUTION
Download PDF FDA Summary Lobob Laboratories, I…