Cleared Traditional

K160859 - OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E)

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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Optimized for regulatory review, auditing and printing
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
Combination Product No
PCCP Authorized No
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.

Regulatory Consultant

Eyereg Consulting, Inc.
BRET ANDRE

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MUW Lens, Contact (orthokeratology)

Devices cleared under the same product code (MUW) and FDA review panel - the closest regulatory comparables to K160859.
iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses
K183200 · C&E GP Specialist, Inc. · Jan 2019
FLUOROPERM 151-OK, PARAGON HDS 100-OK
K010109 · Paragon Vision Sciences · Feb 2001
BOSTON EQUALENS II (OPRIFOCON A) CONTACT LENS FOR ORTHOKERATOLGY
K003933 · Polymer Technology · Feb 2001
FLUROPERM 60-OK, PARAGON HDS-OK
K000224 · Paragon Vision Sciences · Apr 2000
AIRPERM (SIFLUFOCON A) RIGID GAS PERMEABLE OK CONTACT LENSES FOR DAILY WEAR ORTHOKERATOLOGY
K973697 · Airperm, Inc. · Apr 1998