Cleared Traditional

K071736 - AQUAIR (ENFILCON A) SOFT (HYDROPHILIC) CONTACT LENS

K071736 is an FDA 510(k) clearance for AQUAIR (ENFILCON A) SOFT (HYDROPHILIC) ..., manufactured by CooperVision, Inc.. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 192-day FDA review.

K071736 · CooperVision, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2008
Decision
192d
Days
Class 2
Risk

K071736 is an FDA 510(k) clearance for the AQUAIR (ENFILCON A) SOFT (HYDROPHILIC) CONTACT LENS. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by CooperVision, Inc. (Pleasanton, US). The FDA issued a Cleared decision on January 4, 2008 after a review of 192 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K071736

510(k) Number K071736 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2007
Decision Date January 04, 2008
Days to Decision 192 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
82d slower than avg
Panel avg: 110d · This submission: 192d
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 K071736.
VISTAKON (NARAFILCON) A SOFT CONTACT LENS
K073485 · Johnson & Johnson Vision Care, Inc. · Mar 2008
CIBA VISION (LOTRAFILCON B) SOFT CONTACT LENSES
K073459 · Ciba Vision Corporation · Feb 2008
CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES
K072777 · Ciba Vision Corporation · Jan 2008
BENZ-G 4X HIOXIFILCON D
K062854 · Benz Research and Development Corp. · Aug 2007
CALAVIEW COLORS (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS
K062541 · Innova Vision, Inc. · Jun 2007
FLEXLENS MULTIFOCAL SOFT CONTACT LENS, (HIOXIFILCON A) AND (HIOXIFILCON B) FOR DAILY WEAR
K070308 · X-Cel Contacts · Mar 2007
K071736 · AQUAIR (ENFILCON A) SOFT (HYDROPHILIC) CONTACT LENS
Download PDF FDA Summary CooperVision, Inc.