Atlas FDA

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 K223397 · decided 2024-01-03

Clearance details

K-number
K223397
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
2022-11-08
Decision date
2024-01-03
Days to decision
421 days
Clearance type
Traditional
Product code
LPL
Device class
2
Regulation number
886.5925
Medical specialty
Ophthalmic
Advisory committee
Ophthalmic
Location
Amphur Muang, 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.

RecordFirmDate
Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo Plus (K260507)INTEROJO, Inc.2026-05-29
Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Color Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Color Soft (Hydrophilic) Contact Lenses (K253352)Pegavision Corporation2026-05-21
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses (K261299)Pegavision Corporation2026-05-19
PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENS; PUSCON WATER BALANCE-1DAY COLOR (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENSES (K253885)GEO MEDICAL CO., LTD.2026-04-29
Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens (K254269)St. shine Optical Co., Ltd.2026-03-19
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses (K252385)Pegavision Corporation2026-03-13
DAILIES TOTAL1®; DAILIES TOTAL1® Multifocal (K254052)Alcon Laboratories, Inc.2026-02-13
Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Presbyopia (EDOF) (K251683)Bruno Vision Care, LLC2025-12-23
Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens (K250364)St. shine Optical Co., Ltd.2025-10-07
Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear (Daily Wear); Pure Plus UV Aspheric (Otufilcon A) 1-Day Silicone Soft (hydrophilic) Contact Lens (Daily Disposable) (K244009)Yung Sheng Optical Co., Ltd.2025-09-25
Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses (K251095)Pegavision Corporation2025-09-17
VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens (K251573)Vizionfocus, Inc.2025-09-10

Recalls involving this device

No recalls on record reference this clearance.