color contact lens;BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens

Primary DI
86931219451652
Brand
color contact lens;BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens
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 0.50 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. 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.
Published
2025-12-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
false

Product Codes#

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

Product Code Classifications#

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

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
06931219451656PrimaryGS10
86931219451652Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06931219451656069312194516566931219451656
8693121945165286931219451652

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
2
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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
06975326564304color 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
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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.LPL2026-07-17
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06942686576032coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-17
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06942686576063coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-17
06942686576070coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-17
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06942686576100coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-17
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06942686576155coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.LPL2026-07-17
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