Clearance Summary
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 received FDA 510(k) clearance under submission number K261812, sponsored by HOYA Lamphun , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2026-07-07.
- Submission: K261812
- Applicant / Sponsor: HOYA Lamphun , Ltd.
- Clearance pathway: Special
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.5925
- Decision date: 2026-07-07
Classification & Regulation
This clearance is catalogued under FDA product code MVN and 21 CFR 886.5925, within the Ophthalmic review panel as a Class II device.