Cleared Traditional

K964902 - CONTACT LENSES METRO-G 3X (HIOXIFILCON B)

K964902 is an FDA 510(k) clearance for CONTACT LENSES METRO-G 3X (HIOXIFILCON B), manufactured by Metro Optics of Austin, Inc.. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K964902 · Metro Optics of Austin, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1997
Decision
95d
Days
Class 2
Risk

K964902 is an FDA 510(k) clearance for the CONTACT LENSES METRO-G 3X (HIOXIFILCON B). Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Metro Optics of Austin, Inc. (Rosewell, US). The FDA issued a Cleared decision on March 11, 1997 after a review of 95 days - within the typical 510(k) review window.

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.

View all Metro Optics of Austin, Inc. devices

FDA 510(k) Submission Details - K964902

510(k) Number K964902 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1996
Decision Date March 11, 1997
Days to Decision 95 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
15d faster than avg
Panel avg: 110d · This submission: 95d
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 458
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K964902.
MENICON Z BIFOCAL DESIGN LENS/MENICON Z TRIFOCAL DESIGN LENS
K970019 · Menicon U.S.A., Inc. · Mar 1997
PROMED 55-G SOFT DAILY WEAR CONTACT LENS
K970615 · Biomed Devices Corp. · Mar 1997
LIFESTYLE 4-VUE (POLYMACON) HYDROPHILIC MULTIFOCAL CONTACT LENS FOR DAILY WEAR
K963001 · Permeable Technologies, Inc. · Mar 1997
LIFESTYLE BREAK THRU (POLYMACON)
K965012 · The Lifestyle Co., Inc. · Mar 1997
(LENSES) BENZ-G 3X (HIOXIFILCON B) SPHERICAL AND TORIC SOFT (HYDROPHILIC) CONTACT LENSES IN CLEAR AND WITH A BLUE TINT
K964528 · Benz Research and Development Corp. · Mar 1997
SUNSOFT (METHAFILCON A) SOFT (HYDROPHILIC) DAILY WEAR CONTACT LENS
K964696 · Sunsoft Corp. · Feb 1997