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
FDA 510(k) clearance K261812 · decided 2026-07-07
Clearance details
- K-number
- K261812
- Device name
- 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.
- Decision
- Substantially Equivalent
- Date received
- 2026-06-01
- Decision date
- 2026-07-07
- Days to decision
- 36 days
- Clearance type
- Special
- Product code
- MVN
- Device class
- 2
- Regulation number
- 886.5925
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Lamphun, TH
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal (K202448) | Alcon Laboratories, Inc. | 2020-09-22 |
| Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal (K202036) | Alcon Laboratories, Inc. | 2020-08-21 |
| 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. | 2015-06-15 |
| Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens (K143190) | Yung Sheng Optical Co., Ltd. | 2015-01-16 |
| SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENS WITH UV BLOCKER (K130331) | Sauflon Pharmaceuticals, Ltd. | 2013-07-26 |
| NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENS (K112192) | Bausch & Lomb, Inc. | 2011-10-25 |
| CLEAR1-DAY HIOXIFILCON DAILY DISPOSABLE SOFT CONTACT LENS (K080632) | Clearlab SG Pte, Ltd. | 2008-10-15 |
| SOFLENS DAILY DISPOSABLE TORIC (HILAFILCON B) VISIBILITY TINTED CONTACT LENS (K080755) | Bausch & Lomb, Inc. | 2008-06-10 |
| CALAVIEW (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR (K073060) | Innova Vision, Inc. | 2007-11-29 |
| PROCLEAR (OMAFILCON A) DAILY DISPOSABLE/DAILY WEAR SOFT CONTACT LENS (K061948) | CooperVision, Inc. | 2006-11-22 |
| SOFLENS ONE DAY PLUS DISPOSABLE (HILAFILCON B) VISIBILITY TINTED CONTACT LENS (K061157) | Bausch & Lomb | 2006-06-22 |
| SAUFLON NEW DAY (METHAFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENSES (K052832) | Sauflon Pharmaceuticals, Ltd. | 2006-05-15 |
Recalls involving this device
No recalls on record reference this clearance.