Cleared Traditional

K840691 - CONTACT LENS CASE FOR RIGID GAS PERMA

K840691 is an FDA 510(k) clearance for CONTACT LENS CASE FOR RIGID GAS PERMA, manufactured by Optimum Manufacturers, Inc.. The device is a Class 2 Ophthalmic device with product code LRX cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K840691 · Optimum Manufacturers, Inc. · Ophthalmic device
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May 1984
Decision
92d
Days
Class 2
Risk

K840691 is an FDA 510(k) clearance for the CONTACT LENS CASE FOR RIGID GAS PERMA. Classified as Case, Contact Lens (product code LRX), Class II - Special Controls.

Submitted by Optimum Manufacturers, Inc. (Walker, US). The FDA issued a Cleared decision on May 18, 1984 after a review of 92 days - within the typical 510(k) review window.

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: 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.

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FDA 510(k) Submission Details - K840691

510(k) Number K840691 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 1984
Decision Date May 18, 1984
Days to Decision 92 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 110d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LRX Device Classification - Class 2, Special Controls

Product Code LRX Case, Contact Lens
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.