Cleared Special

K052606 - MARIETTA CONTACT LENS (POLYMACON), TINTED DAILY WEAR CONTACT LENS

K052606 is an FDA 510(k) clearance for MARIETTA CONTACT LENS (POLYMACON), manufactured by Marietta Vision. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Special 510(k) pathway after a 84-day FDA review.

K052606 · Marietta Vision · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2005
Decision
84d
Days
Class 2
Risk

K052606 is an FDA 510(k) clearance for the MARIETTA CONTACT LENS (POLYMACON), TINTED DAILY WEAR CONTACT LENS. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Marietta Vision (Grand Junction, US). The FDA issued a Cleared decision on December 15, 2005 after a review of 84 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K052606

510(k) Number K052606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2005
Decision Date December 15, 2005
Days to Decision 84 days
Submission Type Special
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
26d faster than avg
Panel avg: 110d · This submission: 84d
Pathway characteristics
Modification to existing cleared device.

LPL Device Classification - Class 2, Special Controls

Product Code LPL Lenses, Soft Contact, Daily Wear
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 - LPL Lenses, Soft Contact, Daily Wear

All 486
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K052606.
SPECIALEYES 50 AND SPECIALEYES 49 SHPERE AND TORIC SOFT CONTACT LENSES
K060821 · Specialeyes, LLC · May 2006
AQUASOFT ALL-DAY & ALL-DAY T (HIOXIFILCON A) DAILY WEAR CONTACT LENS
K052290 · Clearlab Pte , Ltd. · May 2006
MIGWANG COMFORT 38 (POLYMACON) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR, TINTED AND COSMETIC)
K051477 · Mi Gwang Contact Lens Co., Ltd. · Mar 2006
BIOFINITY (COMFILCON A) SOFT CONTACT LENS
K052560 · CooperVision, Inc. · Dec 2005
ALDEN CLASSIC (POLYMACON) MULTIFOCAL (SPHERICAL AND TORIC), ALDEN CLASSIC 55 (METHAFILCON A) MULTIFOCAL (SPHERICAL
K052703 · Alden Optical Labs., Inc. · Nov 2005
55 UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
K051095 · Optical Connection, Inc. · Aug 2005
K052606 · MARIETTA CONTACT LENS (POLYMACON), TINTED DAILY WEAR CONTACT LENS
Download PDF FDA Summary Marietta Vision