Cleared Traditional

K160859 - OPTIMUM GP OK Daily Wear Contact Lens (...

K160859 is an FDA 510(k) clearance for OPTIMUM GP OK Daily Wear Contact Lens (..., manufactured by Contamac, Ltd.. The device is a Class 2 Ophthalmic device with product code MUW cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K160859 · Contamac, Ltd. · Ophthalmic device
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Jul 2016
Decision
106d
Days
Class 2
Risk

K160859 is an FDA 510(k) clearance for the OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E). Classified as Lens, Contact (orthokeratology) (product code MUW), Class II - Special Controls.

Submitted by Contamac, Ltd. (Saffron Walden, GB). The FDA issued a Cleared decision on July 13, 2016 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5916 - 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 Contamac, Ltd. devices

FDA 510(k) Submission Details - K160859

510(k) Number K160859 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2016
Decision Date July 13, 2016
Days to Decision 106 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 110d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MUW Device Classification - Class 2, Special Controls

Product Code MUW Lens, Contact (orthokeratology)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5916
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.