Cleared Traditional

K080755 - SOFLENS DAILY DISPOSABLE TORIC (HILAFILCON B) VISIBILITY TINTED CONTACT LENS

K080755 is an FDA 510(k) clearance for SOFLENS DAILY DISPOSABLE TORIC (HILAFIL..., manufactured by Bausch & Lomb, Inc.. The device is a Class 2 Ophthalmic device with product code MVN cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K080755 · Bausch & Lomb, Inc. · Ophthalmic device
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Jun 2008
Decision
85d
Days
Class 2
Risk

K080755 is an FDA 510(k) clearance for the SOFLENS DAILY DISPOSABLE TORIC (HILAFILCON B) VISIBILITY TINTED CONTACT LENS. Classified as Lens, Contact, (disposable) (product code MVN), Class II - Special Controls.

Submitted by Bausch & Lomb, Inc. (Rochester, US). The FDA issued a Cleared decision on June 10, 2008 after a review of 85 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

FDA 510(k) Submission Details - K080755

510(k) Number K080755 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2008
Decision Date June 10, 2008
Days to Decision 85 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
25d faster than avg
Panel avg: 110d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MVN Device Classification - Class 2, Special Controls

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 14
Devices cleared under the same product code (MVN) and FDA review panel - the closest regulatory comparables to K080755.
DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal
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K202036 · Alcon Laboratories, Inc. · Aug 2020
NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENS
K112192 · Bausch & Lomb, Inc. · Oct 2011
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