Atlas FDA

Sofclear Enhance (methafilcon A) Daily Wear Contact Lens, Sofclear Colors (methafilcon A) Daily Wear Contact Lens, Sofclear Comfort (methafilcon A) Daily Wear Contact Lens

FDA 510(k) clearance K181558 · decided 2018-09-06

Clearance details

K-number
K181558
Device name
Sofclear Enhance (methafilcon A) Daily Wear Contact Lens, Sofclear Colors (methafilcon A) Daily Wear Contact Lens, Sofclear Comfort (methafilcon A) Daily Wear Contact Lens
Applicant
Gelflex Laboratories
Decision
Substantially Equivalent
Date received
2018-06-13
Decision date
2018-09-06
Days to decision
85 days
Clearance type
Traditional
Product code
LPL
Device class
2
Regulation number
886.5925
Medical specialty
Ophthalmic
Advisory committee
Ophthalmic
Location
Malaga, AU
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
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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.