Cleared Traditional

K050213 - FRESHLOOK ONE-DAY COLOR CONTACT LENS

K050213 is an FDA 510(k) clearance for FRESHLOOK ONE-DAY COLOR CONTACT LENS, manufactured by Ciba Vision Corporation. The device is a Class 2 Ophthalmic device with product code MVN cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K050213 · Ciba Vision Corporation · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2005
Decision
56d
Days
Class 2
Risk

K050213 is an FDA 510(k) clearance for the FRESHLOOK ONE-DAY COLOR CONTACT LENS. Classified as Lens, Contact, (disposable) (product code MVN), Class II - Special Controls.

Submitted by Ciba Vision Corporation (Duluth, US). The FDA issued a Cleared decision on March 28, 2005 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5925 - 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.

FDA 510(k) Submission Details - K050213

510(k) Number K050213 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2005
Decision Date March 28, 2005
Days to Decision 56 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
54d faster than avg
Panel avg: 110d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MVN Device Classification - Class 2, Special Controls

Product Code MVN Lens, Contact, (disposable)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5925
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 Peers - MVN Lens, Contact, (disposable)

All 25
Devices cleared under the same product code (MVN) and FDA review panel - the closest regulatory comparables to K050213.
DISCON DAILY (ETAFILCON A) ONE-DAY SOFT (HYDROPHILIC) CONTACT LENS
K053191 · Innova Vision, Inc. · May 2006
ACUVUE (ETAFILCON A) CONTACT LENS, CLEAR AND WITH VISIBILITY TINT WITH UV BLOCKER, FOR DAILY WEAR
K051900 · Johnson & Johnson Vision Care, Inc. · Aug 2005
FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES
K050065 · Ciba Vision Corporation · May 2005
FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES ONE-DAY SOFT CONTACT LENSES
K033701 · Ciba Vision Corporation · Dec 2003
BIOMEDICS 52 (OCUFILCON B) UV BLOCKING DAILY WEAR SOFT CONTACT LENS
K020389 · Ocular Sciences · Jun 2002
BAUSCH & LOMB SOFLENS ONE DAY DISPOSABLE (HILAFILCON A) VISIBILITY TINTED CONTACT
K011718 · Bausch & Lomb, Inc. · Jul 2001
K050213 · FRESHLOOK ONE-DAY COLOR CONTACT LENS
Download PDF FDA Summary Ciba Vision Corporati…