Cleared Traditional

K003861 - BENZ-MF (VISIBILITY HANGLING TINT) (METHAFILCON A) SOFT DAILY WEAR CONTACT LENS (LATHE-CUT)

K003861 is an FDA 510(k) clearance for BENZ-MF (VISIBILITY HANGLING TINT) (MET..., 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 85-day FDA review.

K003861 · Benz Research and Development Corp. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2001
Decision
85d
Days
Class 2
Risk

K003861 is an FDA 510(k) clearance for the BENZ-MF (VISIBILITY HANGLING TINT) (METHAFILCON A) SOFT DAILY WEAR CONTACT LE.... Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Benz Research and Development Corp. (Grand Junction, US). The FDA issued a Cleared decision on March 8, 2001 after a review of 85 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 - K003861

510(k) Number K003861 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2000
Decision Date March 08, 2001
Days to Decision 85 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
25d faster than avg
Panel avg: 110d · This submission: 85d
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 486
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K003861.
VISTAKON (HEFILCON C) CONTACT LENSES
K010218 · Vistakon · Mar 2001
BIOCURVE SOFT (METHAFILCON A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR, LATHE-CUT)
K010223 · American Contact Lens, Inc. · Mar 2001
PROSTHETIC, GELFLEX ALPHA, (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED)
K010126 · Cl-Tinters · Mar 2001
SPECIALITY 56 UV (HEFILCON C) SOFT (HYDROPHILLIC) CONTACT LENS FOR DAILY WEAR
K003789 · Specialty Ultravision, Inc. · Feb 2001
OCU-FLEX-53 THIN ZONE TORIC AND THIN ZONE TORIC ASPHERICAL (OCUFILCON) SOFT CONTACT LENSES FOR DAILY WEAR
K003996 · Ocu-Ease Optical Products, Inc. · Feb 2001
OCU-FLEX-49 THIN ZONE TORIC AND THIN Z0NE TORIC ASPHERICAL (HIOXIFILCON B) SOFT CONTACT LENSES FOR DAILY WEAR (LATHE-CUT
K004000 · Ocu-Ease Optical Products, Inc. · Feb 2001
K003861 · BENZ-MF (VISIBILITY HANGLING TINT) (METHAFILCON A) SOFT DAILY WEAR CONTACT LENS (LATHE-CUT)
Download PDF FDA Summary Benz Research and Dev…