Cleared Traditional

K042275 - VISTAKON (SENOFILCON A) SOFT CONTACT LENS

K042275 is an FDA 510(k) clearance for VISTAKON (SENOFILCON A) SOFT CONTACT LENS, manufactured by Vistakon. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K042275 · Vistakon · Ophthalmic device
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Oct 2004
Decision
66d
Days
Class 2
Risk

K042275 is an FDA 510(k) clearance for the VISTAKON (SENOFILCON A) SOFT CONTACT LENS. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Vistakon (Tampa, US). The FDA issued a Cleared decision on October 28, 2004 after a review of 66 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.

View all Vistakon devices

FDA 510(k) Submission Details - K042275

510(k) Number K042275 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2004
Decision Date October 28, 2004
Days to Decision 66 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 110d · This submission: 66d
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 295
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K042275.
PROCLEAR ULTRAVUE TORIC, PROCLEAR ULTRAVUE MULTIFOCAL, PROCLEAR ULTRAVUE 200T MULTIFOCAL TORIC
K050717 · CooperVision, Inc. · May 2005
MAXSIGHT (POLYMACON) SPORT-TINTED CONTACT LENS
K050157 · Bausch & Lomb, Inc. · Apr 2005
FREQUENCY 38 AND SILVER 07 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS
K042824 · CooperVision, Inc. · Nov 2004
COOPER PROSTHETIC
K042435 · CooperVision, Inc. · Oct 2004
LEO COLORS, LEO ASPHERIC COLORS, LEO TORIC COLORS
K041138 · CooperVision, Inc. · Jul 2004
CIBA VISION (LOTRAFILCON B) SPHERICAL, TORIC, MULTIFOCAL AND TORIC MULTIFOCAL DESIGNS
K033919 · Ciba Vision Corporation · Mar 2004