Cleared Traditional

K130331 - SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENS WITH UV BLOCKER

K130331 is an FDA 510(k) clearance for SAUFLON CLARITI 1 DAY (SOMOFILCON A) SO..., manufactured by Sauflon Pharmaceuticals, Ltd.. The device is a Class 2 Ophthalmic device with product code MVN cleared through the Traditional 510(k) pathway after a 165-day FDA review.

K130331 · Sauflon Pharmaceuticals, Ltd. · Ophthalmic device
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Jul 2013
Decision
165d
Days
Class 2
Risk

K130331 is an FDA 510(k) clearance for the SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONT.... Classified as Lens, Contact, (disposable) (product code MVN), Class II - Special Controls.

Submitted by Sauflon Pharmaceuticals, Ltd. (Twickenham, Middlesex, GB). The FDA issued a Cleared decision on July 26, 2013 after a review of 165 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Sauflon Pharmaceuticals, Ltd. devices

FDA 510(k) Submission Details - K130331

510(k) Number K130331 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2013
Decision Date July 26, 2013
Days to Decision 165 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d slower than avg
Panel avg: 110d · This submission: 165d
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 13
Devices cleared under the same product code (MVN) and FDA review panel - the closest regulatory comparables to K130331.
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K080755 · Bausch & Lomb, Inc. · Jun 2008
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K061948 · CooperVision, Inc. · Nov 2006
FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES
K050065 · Ciba Vision Corporation · May 2005