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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 489
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K042275.
HORIZON 59 OASIS (HIOXIFILCON A) DAILY WEAR CONTACT LENSES
K043540 · Westcon Contact Lens Co., Inc. · Feb 2005
PROCLEAR ULTRAVUE MULTIFOCAL AND PROCLEAR ULTRAVUE 2000T MULTIFOCAL TORIC (OMAFLICON A) SOFT (HYDROPHILIC CONTACT LENS)
K043129 · Opti-Centre Laboratories · Jan 2005
FREQUENCY 38 AND SILVER 07 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS
K042824 · CooperVision, Inc. · Nov 2004
COOPER PROSTHETIC
K042435 · CooperVision, Inc. · Oct 2004
ALDEN HP (HIOXIFILCON B) SPHERE & TORIC SOFT CONTACT LENSES
K042242 · Alden Optical Labs., Inc. · Sep 2004
SOFLEX SOFT K (XYLOFILCON A) SOFT (HYDROPHILIC) KERATOCONUS CONTACT LENS FOR DAILY WEAR
K033655 · Soflex Contact Lens Industries , Ltd. · Jul 2004
K042275 · VISTAKON (SENOFILCON A) SOFT CONTACT LENS
Download PDF FDA Summary Vistakon