Cleared Special

K261812 - HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens

Also marketed or referenced as:
HOYA Illumina (sorafilcon A) Toric Daily Disposable Soft Contact Lens HOYA Illumina (sorafilcon A) Multifocal Daily Disposable Soft Contact Lens

K261812 is an FDA 510(k) clearance for HOYA Illumina (sorafilcon A) Daily Disp..., manufactured by Hoya Lamphun , Ltd.. The device is a Class 2 Ophthalmic device with product code MVN cleared through the Special 510(k) pathway after a 36-day FDA review.

K261812 · Hoya Lamphun , Ltd. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2026
Decision
36d
Days
Class 2
Risk

K261812 is an FDA 510(k) clearance for the HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens. Classified as Lens, Contact, (disposable) (product code MVN), Class II - Special Controls.

Submitted by Hoya Lamphun , Ltd. (Lamphun, TH). The FDA issued a Cleared decision on July 7, 2026 after a review of 36 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 Hoya Lamphun , Ltd. devices

FDA 510(k) Submission Details - K261812

510(k) Number K261812 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2026
Decision Date July 07, 2026
Days to Decision 36 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
74d faster than avg
Panel avg: 110d · This submission: 36d
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 17
Devices cleared under the same product code (MVN) and FDA review panel - the closest regulatory comparables to K261812.
DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal
K202448 · Alcon Laboratories, Inc. · Sep 2020
Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal
K202036 · Alcon Laboratories, Inc. · Aug 2020
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
NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENS
K112192 · Bausch & Lomb, Inc. · Oct 2011