FDA.reportPublic FDA data

FreshKon® (Methafilcon A)

Primary DI
08886428047382
Brand
FreshKon® (Methafilcon A)
Company
OCULUS PRIVATE LIMITED
Model
Alluring Eye, Mosaic,Colors Fusion
Device description
Two sterile daily wear soft contact lenses, 45% methafilcon A, 55% water, immersed in 0.9% buffered saline.Indication for use: The FreshKon® Contact Lens is indicated for daily wear for the correction of refractive ametropia(myopia) in aphakic or not‐aphakic persons with non‐diseased eyes. The lens may be disinfected using a chemical disinfection system.Eye Care Professionals may prescribe the lens for frequent replacement wear, with cleaning disinfection and scheduled replacement (see WEARING SCHEDULE) When prescribed for frequent replacement wear,the lens may be disinfected using a chemical disinfection system.
Published
2016-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LPLLenses, Soft Contact, Daily Wear

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LPLLenses, Soft Contact, Daily WearOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08886428047382PrimaryGS10
08886428047757Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08886428047382088864280473828886428047382
08886428047757088864280477578886428047757

GMDN Terms#

Term, Definition table
TermDefinition
Soft corrective contact lens, daily-wearA soft ophthalmic lens intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct refractive vision conditions that occur naturally (e.g., myopia, hyperopia, astigmatism, presbyopia) or post surgery; it is designed to be removed prior to sleeping each night. The device may be coloured/tinted for easier handling or to change the appearance of the eye for cosmetic purposes; it may include an ultraviolet blocker. The device is made of various synthetic polymer materials, the main polymer molecules being hydrophilic (e.g., hydrogel); it permits diffusion of oxygen (O2) to the ocular surface. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter14.2Millimeter

Contacts#

Phone, Email table
PhoneEmail
18558290813singapore@oculuslens.com

Regulatory Flags#

DUNS number
936888460
Device count
2
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08886428047368FreshKon® 1-Day (Etafilcon A)Alluring Eye,Mosaic,Colors Fusion2016-09-15
08886428047375FreshKon® 1-Day (Etafilcon A)Alluring Eye, Colors Fusion,Mosaic2016-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06942686582736mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-23
06942686582743mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-23
06942686582750mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-23
06942686582767mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-23
06942686582774mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-23
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06942686582804mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-23
06942686582811mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-23
06942686582828mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-23
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