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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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 25
Devices cleared under the same product code (MVN) and FDA review panel - the closest regulatory comparables to K080755.
SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENS WITH UV BLOCKER
K130331 · Sauflon Pharmaceuticals, Ltd. · Jul 2013
NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENS
K112192 · Bausch & Lomb, Inc. · Oct 2011
CLEAR1-DAY HIOXIFILCON DAILY DISPOSABLE SOFT CONTACT LENS
K080632 · Clearlab SG Pte, Ltd. · Oct 2008
CALAVIEW (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
K073060 · Innova Vision, Inc. · Nov 2007
PROCLEAR (OMAFILCON A) DAILY DISPOSABLE/DAILY WEAR SOFT CONTACT LENS
K061948 · CooperVision, Inc. · Nov 2006
SOFLENS ONE DAY PLUS DISPOSABLE (HILAFILCON B) VISIBILITY TINTED CONTACT LENS
K061157 · Bausch & Lomb · Jun 2006
K080755 · SOFLENS DAILY DISPOSABLE TORIC (HILAFILCON B) VISIBILITY TINTED CONTACT LENS
Download PDF FDA Summary Bausch & Lomb, Inc.