510(k) · Cleared
ClearedHOYA 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
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
HOYA Lamphun, Ltd. · MVN Lens, Contact, (Disposable)
Cleared on Jul 7, 2026 as substantially equivalent to K223397 (Hoya Lamphun, Ltd., 2024) after a 36-day review. Its family tree reaches back 9 generations to 1981.
- Decided
- Jul 7, 2026
- Review
- 36 days
- Class
- Class II
- Product code
- MVN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to P810005 (1981). 21 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backP810005 Weicon (R) (Tefilicon) Hydrophilic Contact LensCiba Vision Care · 1981
- 5 generations between
- 3 generations backK131378 Sus (Stenfilcon a) Contact LensCooperVision, Inc. · 2013 · Recalled
- 2 generations backK191763 MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay…CooperVision, Inc. · 2020
- 1 generation backK223397 HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens…Hoya Lamphun, Ltd. · 2024
- This deviceK261812 HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens…HOYA Lamphun, Ltd. · 2026
Show all 9 generations
- Root · 9 generations backP810005 Weicon (R) (Tefilicon) Hydrophilic Contact LensCiba Vision Care · 1981
- 8 generations backK970746 SEE3 (Lotrafilcon a) Soft Contact LensCiba Vision Corporation · 1997
- 7 generations backK020139 Focus Excelens (Lotrafilcon B) Spherical, Toric and Multifocal DesignCiba Vision Corporation · 2002
- 6 generations backK033919 Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric…Ciba Vision Corporation · 2004 · Recalled
- 5 generations backK052560 Biofinity (Comfilcon a) Soft Contact LensCooperVision, Inc. · 2005 · Recalled
- 4 generations backK071736 Aquair (Enfilcon a) Soft (Hydrophilic) Contact LensCooperVision, Inc. · 2008 · Recalled
- 3 generations backK131378 Sus (Stenfilcon a) Contact LensCooperVision, Inc. · 2013 · Recalled
- 2 generations backK191763 MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay…CooperVision, Inc. · 2020
- 1 generation backK223397 HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens…Hoya Lamphun, Ltd. · 2024
- This deviceK261812 HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens…HOYA Lamphun, Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | P810005 | Weicon (R) (Tefilicon) Hydrophilic Contact Lens | Ciba Vision Care | 1981 | — |
| −8 | K970746 | SEE3 (Lotrafilcon a) Soft Contact Lens | Ciba Vision Corporation | 1997 | — |
| −7 | K020139 | Focus Excelens (Lotrafilcon B) Spherical, Toric and Multifocal Design | Ciba Vision Corporation | 2002 | — |
| −6 | K033919 | Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric Multifocal… | Ciba Vision Corporation | 2004 | 1 |
| −5 | K052560 | Biofinity (Comfilcon a) Soft Contact Lens | CooperVision, Inc. | 2005 | 1 |
| −4 | K071736 | Aquair (Enfilcon a) Soft (Hydrophilic) Contact Lens | CooperVision, Inc. | 2008 | 2 |
| −3 | K131378 | Sus (Stenfilcon a) Contact Lens | CooperVision, Inc. | 2013 | 5 |
| −2 | K191763 | MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay (Stenfilcon A)… | CooperVision, Inc. | 2020 | — |
| −1 | K223397 | HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens, HOYA Illumina… | Hoya Lamphun, Ltd. | 2024 | — |
| 0 (this device) | K261812 | HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens; HOYA Illumina… | HOYA Lamphun, Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2005 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MVN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MVN device
- #1 K202448 DAILIES AquaComfort Plus (DACP) / DACP…score 2.2 · 8 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K223397 | HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens, HOYA Illumina…Summary page 5…con A) Daily Disposable Soft Contact Lens with Reactive Blue 246 as visibility handling tint is substantially equivalent to the following predicate devices cleared under K223397: HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens HOYA Illumina (sorafilcon A) Toric Daily Disposable Soft C… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 45 years and passes through 4 companies; a new generation was cleared every 3.8 years on median.
- 6 of the 21 ancestors have a recall of any class.
How does its category compare?
All MVN devicesMVN Lens, Contact, (Disposable): FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · MVN
2in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · MVN
Too few MVN 510(k)s in any year since 2007 to give a median.
Recalls per year · MVN
2in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MVN
22in 2025
MAUDE reports naming product code MVN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 1 | 0 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 1 | — | 1 | 9 |
| 2012 | 0 | — | 0 | 25 |
| 2013 | 1 | — | 2 | 35 |
| 2014 | 0 | — | 0 | 20 |
| 2015 | 2 | — | 0 | 10 |
| 2016 | 0 | — | 0 | 18 |
| 2017 | 0 | — | 0 | 23 |
| 2018 | 0 | — | 0 | 32 |
| 2019 | 0 | — | 0 | 34 |
| 2020 | 2 | — | 0 | 32 |
| 2021 | 0 | — | 0 | 24 |
| 2022 | 0 | — | 0 | 18 |
| 2023 | 0 | — | 0 | 24 |
| 2024 | 0 | — | 0 | 25 |
| 2025 | 0 | — | 0 | 22 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens is indicated for the correction of refractive ametropia (myopia or hyperopia) in non-aphakic person with non-diseased eyes in spherical powers ranging from +5.00D to -12.00D, exhibiting astigmatism of 1.00 diopter or less that does not interfere with visual acuity. The HOYA Illumina (sorafilcon A) Toric Daily Disposable Soft Contact Lens is indicated for the correction of refractive…
Read the full statement (197 words)
The HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens is indicated for the correction of refractive ametropia (myopia or hyperopia) in non-aphakic person with non-diseased eyes in spherical powers ranging from +5.00D to -12.00D, exhibiting astigmatism of 1.00 diopter or less that does not interfere with visual acuity.
The HOYA Illumina (sorafilcon A) Toric Daily Disposable Soft Contact Lens is indicated for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in non-aphakic person with non-diseased eyes in spherical powers ranging from +5.00D to -10.00D. The lenses may be worn by persons who exhibit astigmatism of up to 2.75 diopters that does not interfere with visual acuity.
The HOYA Illumina (sorafilcon A) Multifocal Daily Disposable Soft Contact Lens is indicated for the correction of refractive ametropia (myopia or hyperopia) and presbyopia in non-aphakic person with non-diseased eyes in spherical powers ranging from +5.00D to -10.00D with add power ranging from +0.50D to +2.50D. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopter or less that does not interfere with visual acuity.
The sorafilcon A contact lenses are to be prescribed for single-use disposable wear and are to be discarded upon each removal.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K261812 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261812: 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.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261812
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026