# K223397: 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

- Pathway: 510(k) (Traditional)
- Applicant: Hoya Lamphun, Ltd.
- Decided: Jan 3, 2024 after 421 days
- Product code: LPL (Lenses, Soft Contact, Daily Wear)
- Device class: 2
- Regulation: 21 CFR 886.5925
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to P810005 (1981). 20 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191763: MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay (Stenfilcon A) MULTIFOCAL, MyDay (Stenfilcon A) MULTIFOCAL TORIC, CooperVision, Inc. (2020) Summary page 5.
- K131208: Bausch + Lomb Procomfort (Samfilcon a) Contact Lens, Bausch + Lomb Procomfort (Samfilcon a) Contact Lens for Presbyopia,, Bausch & Lomb, Inc. (2013) Summary page 6.

## Most influential descendants
- 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 (2026), 0 descendants of its own

## Indications for use
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 worm 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.

Source page: https://510kreport.com/device/K223397
Methodology: https://510kreport.com/methodology