Cleared Traditional

K941370 - BAUSCH & LOMB MEDALIST 66 (ALPHAFILCON ...

K941370 is the FDA 510(k) clearance for BAUSCH & LOMB MEDALIST 66 (ALPHAFILCON ... by Bausch & Lomb, Inc.. It is a Class 2 Ophthalmic device (product code LPL) cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K941370 · Bausch & Lomb, Inc. · Ophthalmic device
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May 1994
Decision
66d
Days
Class 2
Risk

K941370 is an FDA 510(k) clearance for the BAUSCH & LOMB MEDALIST 66 (ALPHAFILCON A) VISIBILITY TINTED CONTACT LENS. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Bausch & Lomb, Inc. (Rochester, US). The FDA issued a Cleared decision on May 27, 1994 after a review of 66 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 Bausch & Lomb, Inc. devices

Submission Details

510(k) Number K941370 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 1994
Decision Date May 27, 1994
Days to Decision 66 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
44d faster than avg
Panel avg: 110d · This submission: 66d
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.