Cleared Traditional

K940777 - BAYVUE (POLYMACON) SOFT (HYDROPHILIC) C...

K940777 is the FDA 510(k) clearance for BAYVUE (POLYMACON) SOFT (HYDROPHILIC) C... by Unilens Corp., USA. It is a Class 2 Ophthalmic device (product code LPL) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K940777 · Unilens Corp., USA · Ophthalmic device
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Apr 1994
Decision
49d
Days
Class 2
Risk

K940777 is an FDA 510(k) clearance for the BAYVUE (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Unilens Corp., USA (Largo, US). The FDA issued a Cleared decision on April 12, 1994 after a review of 49 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.

View all Unilens Corp., USA devices

Submission Details

510(k) Number K940777 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 1994
Decision Date April 12, 1994
Days to Decision 49 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 110d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.