Cleared Special

K061157 - SOFLENS ONE DAY PLUS DISPOSABLE (HILAFI...

K061157 is the FDA 510(k) clearance for SOFLENS ONE DAY PLUS DISPOSABLE (HILAFI... by Bausch & Lomb. It is a Class 2 Ophthalmic device (product code MVN) cleared through the Special 510(k) pathway after a 57-day FDA review.

K061157 · Bausch & Lomb · Ophthalmic device
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Jun 2006
Decision
57d
Days
Class 2
Risk

K061157 is an FDA 510(k) clearance for the SOFLENS ONE DAY PLUS DISPOSABLE (HILAFILCON B) VISIBILITY TINTED CONTACT LENS. Classified as Lens, Contact, (disposable) (product code MVN), Class II - Special Controls.

Submitted by Bausch & Lomb (Rochester, US). The FDA issued a Cleared decision on June 22, 2006 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Bausch & Lomb devices

Submission Details

510(k) Number K061157 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2006
Decision Date June 22, 2006
Days to Decision 57 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 110d · This submission: 57d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MVN Lens, Contact, (disposable)
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 - MVN Lens, Contact, (disposable)

All 13
Devices cleared under the same product code (MVN) and FDA review panel - the closest regulatory comparables to K061157.
NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENS
K112192 · Bausch & Lomb, Inc. · Oct 2011
SOFLENS DAILY DISPOSABLE TORIC (HILAFILCON B) VISIBILITY TINTED CONTACT LENS
K080755 · Bausch & Lomb, Inc. · Jun 2008
PROCLEAR (OMAFILCON A) DAILY DISPOSABLE/DAILY WEAR SOFT CONTACT LENS
K061948 · CooperVision, Inc. · Nov 2006
FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES
K050065 · Ciba Vision Corporation · May 2005
FRESHLOOK ONE-DAY COLOR CONTACT LENS
K050213 · Ciba Vision Corporation · Mar 2005
FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES ONE-DAY SOFT CONTACT LENSES
K033701 · Ciba Vision Corporation · Dec 2003