Cleared Traditional

K983836 - RIGID GAS PERMEABLE CONTACT LENS SOLUTION

K983836 is an FDA 510(k) clearance for RIGID GAS PERMEABLE CONTACT LENS SOLUTION, manufactured by Polymer Technology Div. Wilmington Partners, L.P.. The device is a Class 2 Ophthalmic device with product code MRC cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K983836 · Polymer Technology Div. Wilmington Partners, L.P. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1999
Decision
104d
Days
Class 2
Risk

K983836 is an FDA 510(k) clearance for the RIGID GAS PERMEABLE CONTACT LENS SOLUTION. Classified as Products, Contact Lens Care, Rigid Gas Permeable (product code MRC), Class II - Special Controls.

Submitted by Polymer Technology Div. Wilmington Partners, L.P. (Rochester, US). The FDA issued a Cleared decision on February 11, 1999 after a review of 104 days - within the typical 510(k) review window.

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 Polymer Technology Div. Wilmington Partners, L.P. devices

FDA 510(k) Submission Details - K983836

510(k) Number K983836 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 1998
Decision Date February 11, 1999
Days to Decision 104 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
6d faster than avg
Panel avg: 110d · This submission: 104d
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 23
Devices cleared under the same product code (MRC) and FDA review panel - the closest regulatory comparables to K983836.
RGP MULTI-PURPOSE SOLUTION ID 100136
K000148 · Alcon Laboratories · Apr 2000
HYLASHIELD CL
K994170 · Biomatrix, Inc. · Mar 2000
SOLO-CARE BRAND HARD SOLUTION
K993949 · Ciba Vision Corporation · Jan 2000
SOLO-CARE BRAND MULTI-PURPOSE SOLUTION
K983291 · Ciba Vision Corporation · Nov 1998
BOSTON ADVANCE CLEANER
K974466 · Polymer Technology Corp. · Feb 1998