Cleared Traditional

K000975 - LIPIDURE REWETTING DROPS

K000975 is an FDA 510(k) clearance for LIPIDURE REWETTING DROPS, manufactured by Nof Corp.. The device is a Class 2 Ophthalmic device with product code MRC cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K000975 · Nof Corp. · Ophthalmic device
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Sep 2000
Decision
182d
Days
Class 2
Risk

K000975 is an FDA 510(k) clearance for the LIPIDURE REWETTING DROPS. Classified as Products, Contact Lens Care, Rigid Gas Permeable (product code MRC), Class II - Special Controls.

Submitted by Nof Corp. (Wilmington, US). The FDA issued a Cleared decision on September 25, 2000 after a review of 182 days - an extended review 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: 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 Nof Corp. devices

FDA 510(k) Submission Details - K000975

510(k) Number K000975 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 2000
Decision Date September 25, 2000
Days to Decision 182 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d slower than avg
Panel avg: 110d · This submission: 182d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 24
Devices cleared under the same product code (MRC) and FDA review panel - the closest regulatory comparables to K000975.
MENICON PROGENT REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSES
K020930 · Menicon Co, Ltd. · May 2002
AQUIFY LENS COMFORT DROPS
K013204 · Ciba Vision Corporation · Apr 2002
MENICON PROGENT REMOVER
K002140 · Menicon Co, Ltd. · Oct 2000
SOLO-CARE BRAND HARD SOLUTION
K000607 · Ciba Vision Corporation · May 2000
RGP MULTI-PURPOSE SOLUTION ID 100136
K000148 · Alcon Laboratories · Apr 2000
HYLASHIELD CL
K994170 · Biomatrix, Inc. · Mar 2000