Cleared Traditional

K983773 - BENZ G-5X (HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS

K983773 is an FDA 510(k) clearance for BENZ G-5X (HIOXIFILCON A) SOFT DAILY WE..., 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 57-day FDA review.

K983773 · Benz Research and Development Corp. · Ophthalmic device
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Dec 1998
Decision
57d
Days
Class 2
Risk

K983773 is an FDA 510(k) clearance for the BENZ G-5X (HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS. 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 December 22, 1998 after a review of 57 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 - K983773

510(k) Number K983773 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1998
Decision Date December 22, 1998
Days to Decision 57 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 110d · This submission: 57d
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 K983773.
FREQUENCY 55 UV (METHAFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED WITH UV BLOCKER)
K982997 · Aspect Vision Care, Ltd. · Jan 1999
PRECISION UV (VASURFILCON A)
K982988 · Wesley Jessen Corp. · Jan 1999
DURASOFT 3 UV (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC CONTAC LENSES, DURASOFT 3 UV (PHEMFILCON A) SPHERICAL (HYDROPHIS
K982344 · Wesley Jessen Corp. · Dec 1998
OXYLENS TINTED, PROSTHETIC (HIOXIFILCON B) TINTED, SOFT DAILY WEAR CONTACT LENS (SIGHTED AN NON-SIGHTED EYES)
K983278 · Alden Optical Labs., Inc. · Nov 1998
BAUSCH & LOMB PHOENIX (HILAFILCON A) VISIBILITY TINTED CONTACT LENS
K983894 · Bausch & Lomb, Inc. · Nov 1998
METROSOFT II, METROSOFT TORIC, METROLITE, METROTINT, SATUREYES, SATUREYES TORIC, SATUREYES LITE, SATUREYES LITE TORIC
K983021 · Metrosoft, Inc. · Nov 1998
K983773 · BENZ G-5X (HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS
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