Cleared Special

K112192 - NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENS

K112192 is an FDA 510(k) clearance for NATURELLE DAILY DISPOSABLE (HILAFILCON ..., manufactured by Bausch & Lomb, Inc.. The device is a Class 2 Ophthalmic device with product code MVN cleared through the Special 510(k) pathway after a 88-day FDA review.

K112192 · Bausch & Lomb, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2011
Decision
88d
Days
Class 2
Risk

K112192 is an FDA 510(k) clearance for the NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY 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 October 25, 2011 after a review of 88 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.

FDA 510(k) Submission Details - K112192

510(k) Number K112192 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2011
Decision Date October 25, 2011
Days to Decision 88 days
Submission Type Special
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
22d faster than avg
Panel avg: 110d · This submission: 88d
Pathway characteristics
Modification to existing cleared device.

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 K112192.
Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear, Eye Secret 55 UV Aspheric ( methafilcon A) Soft (hydrophilic) Contact lens for Daily Wear
K150630 · Yung Sheng Optical Co., Ltd. · Jun 2015
Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens
K143190 · Yung Sheng Optical Co., Ltd. · Jan 2015
SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENS WITH UV BLOCKER
K130331 · Sauflon Pharmaceuticals, Ltd. · Jul 2013
CLEAR1-DAY HIOXIFILCON DAILY DISPOSABLE SOFT CONTACT LENS
K080632 · Clearlab SG Pte, Ltd. · Oct 2008
SOFLENS DAILY DISPOSABLE TORIC (HILAFILCON B) VISIBILITY TINTED CONTACT LENS
K080755 · Bausch & Lomb, Inc. · Jun 2008
CALAVIEW (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
K073060 · Innova Vision, Inc. · Nov 2007
K112192 · NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENS
Download PDF FDA Summary Bausch & Lomb, Inc.