Cleared Traditional

K013220 - HD/HDT, PV/PVT (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, FULLY CAST-MOLDED LENS)

K013220 is an FDA 510(k) clearance for HD/HDT, manufactured by Poly Vue Technolgies, Inc.. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K013220 · Poly Vue Technolgies, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2001
Decision
55d
Days
Class 2
Risk

K013220 is an FDA 510(k) clearance for the HD/HDT, PV/PVT (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED.... Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Poly Vue Technolgies, Inc. (Grand Junction, US). The FDA issued a Cleared decision on November 20, 2001 after a review of 55 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 - K013220

510(k) Number K013220 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2001
Decision Date November 20, 2001
Days to Decision 55 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
55d faster than avg
Panel avg: 110d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 489
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K013220.
SAUFLON 55 UV SOFT (HYDROPHILIC) CONTACT LENS
K013649 · Sauflon Pharmaceuticals, Ltd. · Dec 2001
BIOMEDICS UV COLORS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS
K013377 · Ocular Sciences Puerto Rico, Inc. · Dec 2001
COSMETICA (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENSES
K011893 · Contact Color Srl · Dec 2001
TORIC EYE-Q (XYLOFILCON A) SOFT (HYDROPHILIC) TORIC MULTIFOCAL CONTACT LENS FOR DAILY WEAR
K013467 · Soflex Contact Lens Industries , Ltd. · Nov 2001
EYE-Q (XYLOFILCON A) SOFT (HYDROPHILIC) MULTIFOCAL CONTACT LENS FOR DAILY WEAR
K013469 · Soflex Contact Lens Industries , Ltd. · Nov 2001
BIOMEDICS UV MULTIFOCAL
K012425 · Ocular Sciences Puerto Rico, Inc. · Oct 2001
K013220 · HD/HDT, PV/PVT (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, FULLY CAST-MOLDED LENS)
Download PDF FDA Summary Poly Vue Technolgies,…