Cleared Traditional

K160859 - OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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.