color contact lens, BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Len

Primary DI
06975326564304
Brand
color contact lens, BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Len
Company
Shenzhen Dashicheng Optical Technology Co., Ltd.
Model
BARBIE
Device description
BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens are indicated for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes with myopia. The lens may be worn by persons who exhibit refractive astigmatism of diopters or less where the astigmatism does not interfere with visual acuity. The lens is available tinted and used to enhance or alter the apparent color of the eye. Daily wear replacement schedules may vary from patient to patient and should be decided by eyecare practitioners in consultation with their patients.Frequent/Planned Replacement Wear:Eyecare practitioners may prescribe any of the above lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.Disposable Wear:Eyecare practitioners may prescribe any of the above lenses for Daily Disposable Wear. When prescribed for Daily Disposable Wear, the lenses are not to be used with disinfecting systems as they are to be discarded after a single use.
Published
2024-03-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true

Product Codes#

Code, Name table
CodeName
LPLLenses, Soft Contact, Daily Wear
MVNLens, Contact, (Disposable)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LPLLenses, Soft Contact, Daily WearOphthalmic2
MVNLens, Contact, (Disposable)Ophthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220143000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220143000BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact LensShenzhen Dashicheng Optical Technology Co., Ltd.2022-09-08LPL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06975326564304PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975326564304069753265643046975326564304

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
543028405
Device count
1
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
06931219451656color contact lens;BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact LensBARBIE2025-12-10
86931219451652color contact lens;BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact LensBARBIE2025-12-10
06931219454961color contact lens;BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact LensBARBIE2025-11-17
86931219454967color contact lens;BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact LensBARBIE2025-11-17
06931219444658Huneyes; BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact LensBARBIE2025-09-17
86931219444654Huneyes; BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact LensBARBIE2025-09-17
06931219402290Unicoeye;BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact LensBARBIE2025-03-18
06975326561525Miiemo; BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact LensBARBIE 2024-10-14
06975326564298color contact lens, BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact LenBARBIE2024-03-11
06975326561501Moody; BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact LensBARBIE2023-06-19
06975326560979Lensweets; BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact LensBARBIE2023-05-22
06975326561051Miiemo; BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact LensBARBIE2023-05-22
06975326561259Unicoeye; BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact LensBARBIE2023-05-22
06975326567763Lensweets; BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact LensBARBIE2023-05-22
06975326567770Miiemo; BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact LensBARBIE2023-05-22
06975326567787Unicoeye; BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact LensBARBIE2023-05-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06942686575905coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-07-17
06942686575912coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-07-17
06942686575912coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-17
06942686575929coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-07-17
06942686575929coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-17
06942686575936coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-07-17
06942686575936coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-17
06942686575943coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-07-17
06942686575943coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-17
06942686575950coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-07-17
06942686575950coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-17
06942686575967coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-07-17
06942686575967coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-17
06942686575974coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-17
06942686575974coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-07-17
06942686575981coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-07-17
06942686575981coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-17
06942686575998coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-07-17
06942686575998coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-17
06942686576001coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-07-17
06942686576001coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-17
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06942686576025coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-07-17
06942686576025coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-17
06942686576032coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.MVN2026-07-17
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