HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens +2 more— 510(k) K261812
Substantially EquivalentHOYA Lamphun , Ltd.
FDA 510(k) clearance K261812 for HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens +2 more, Substantially Equivalent on 2026-07-07. Applicant: HOYA Lamphun , Ltd.. Device class: 2.
Summary
HOYA Lamphun's clearance covers the HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens plus Toric and Multifocal versions of it. They're filed under MVN, disposable contact lenses, and the record doesn't give powers or parameters.
Class II, 21 CFR 886.5925. Ophthalmic is both the classification panel and the review panel, and it came in as a Special 510(k).
HOYA Lamphun filed from Lamphun, Thailand. The decision came 36 calendar days after FDA received it (June 1 to July 7, 2026).
Clearance details
- Device name as filed
- HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens; HOYA Illumina (sorafilcon A) Toric Daily Disposable Soft Contact Lens; HOYA Illumina (sorafilcon A) Multifocal Daily Disposable Soft Contact Lens
- Applicant
- HOYA Lamphun , Ltd.
- Product code
- Product code MVN
- Device class
- Class 2
- Regulation
- 21 CFR 886.5925
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Lamphun, TH
Recent devices under product code MVN
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- K150630 — 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
- K143190 — Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens
- K130331 — SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENS WITH UV BLOCKER
More clearances from HOYA Lamphun , Ltd.
view allAdverse events under product code MVN
product code MVN- Injury
- 149
- Total
- 149
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.