Cleared Traditional

K994125 - BAUSCH & LOMB 2-WEEK (HILAFILCON B) VIS...

K994125 is the FDA 510(k) clearance for BAUSCH & LOMB 2-WEEK (HILAFILCON B) VIS... by Bausch & Lomb, Inc.. It is a Class 2 Ophthalmic device (product code LPL) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K994125 · Bausch & Lomb, Inc. · Ophthalmic device
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Mar 2000
Decision
87d
Days
Class 2
Risk

K994125 is an FDA 510(k) clearance for the BAUSCH & LOMB 2-WEEK (HILAFILCON B) VISIBILITY TINTED CONTACT LENSES. 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 March 3, 2000 after a review of 87 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 K994125 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1999
Decision Date March 03, 2000
Days to Decision 87 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
23d faster than avg
Panel avg: 110d · This submission: 87d
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.

Regulatory Peers - LPL Lenses, Soft Contact, Daily Wear

All 139
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K994125.
POLYMACON
K001089 · CooperVision, Inc. · May 2000
METHAFILCON A
K001090 · CooperVision, Inc. · May 2000
FREQUENCY 55, FREQUENCY 55 ASPHERIC, ENCORE, ENCORE TORIC, ONEVIEW, COOPERFLEX
K000384 · CooperVision, Inc. · Mar 2000
TETRAFILCON A
K990606 · CooperVision, Inc. · Mar 1999
BAUSCH & LOMB PHOENIX (HILAFILCON A) VISIBILITY TINTED CONTACT LENS
K983894 · Bausch & Lomb, Inc. · Nov 1998
PREFERENCE STANDARD, PREFERENCE TORIC, COOPER TORIC, COOPERCLEAR, COOPERHT, CB 43, VANTAGE, VANTAGE ACCENTS
K980649 · CooperVision, Inc. · May 1998