Cleared Traditional

K964528 - (LENSES) BENZ-G 3X (HIOXIFILCON B) SPHERICAL AND TORIC SOFT (HYDROPHILIC) CONTACT LENSES IN CLEAR AND WITH A BLUE TINT

K964528 is an FDA 510(k) clearance for (LENSES) BENZ-G 3X (HIOXIFILCON B) SPHE..., manufactured by Benz Research and Development Corp.. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K964528 · Benz Research and Development Corp. · Ophthalmic device
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Optimized for regulatory review, auditing and printing
Mar 1997
Decision
115d
Days
Class 2
Risk

K964528 is an FDA 510(k) clearance for the (LENSES) BENZ-G 3X (HIOXIFILCON B) SPHERICAL AND TORIC SOFT (HYDROPHILIC) CON.... Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Benz Research and Development Corp. (Rosewell, US). The FDA issued a Cleared decision on March 7, 1997 after a review of 115 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 Benz Research and Development Corp. devices

FDA 510(k) Submission Details - K964528

510(k) Number K964528 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1996
Decision Date March 07, 1997
Days to Decision 115 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
5d slower than avg
Panel avg: 110d · This submission: 115d
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 191
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K964528.
PROMED 55-G SOFT DAILY WEAR CONTACT LENS
K970615 · Biomed Devices Corp. · Mar 1997
CONTACT LENSES METRO-G 3X (HIOXIFILCON B)
K964902 · Metro Optics of Austin, Inc. · Mar 1997
LIFESTYLE BREAK THRU (POLYMACON)
K965012 · The Lifestyle Co., Inc. · Mar 1997
SUNSOFT (METHAFILCON A) SOFT (HYDROPHILIC) DAILY WEAR CONTACT LENS
K964696 · Sunsoft Corp. · Feb 1997
VISTAKON (GENFILCON A) CONTACT LENS, CLEAR AND WITH VISIBILIITY TINT
K964612 · Vistakon, Johnson & Johnson Vision Products, Inc. · Jan 1997
HYDRASOFT (EAST) AND HYDRASOFT TORIC(EAST) (METHAFILCON B) DAILY WEAR SOFT HYDROPHILIC CONTACT LENS
K962185 · CooperVision, Inc. · Dec 1996