Cleared Traditional

K183200 - iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses (FDA 510(k) Clearance)

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

K183200 · C&E GP Specialist, Inc. · Ophthalmic device
Jan 2019
Decision
51d
Days
Class 2
Risk

K183200 is an FDA 510(k) clearance for the iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses. Classified as Lens, Contact (orthokeratology) (product code MUW), Class II - Special Controls.

Submitted by C&E GP Specialist, Inc. (San Diego, US). The FDA issued a Cleared decision on January 9, 2019 after a review of 51 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

Submission Details

510(k) Number K183200 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2018
Decision Date January 09, 2019
Days to Decision 51 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 156d · This submission: 51d
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.