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Unicoeye +1 more model

FDA UDI

Class II (US FDA UDI)

by Shenzhen Dashicheng Optical Technology Co., Ltd.

Identity

Trade Name
Unicoeye; BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens FDA UDI
Generic Name
Soft corrective contact lens, daily-disposable FDA UDI
Device Name
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. 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. FDA UDI
Model / Reference
BARBIE FDA UDI
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. 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. FDA UDI

Identifiers

Primary DI / UDI-DI
06975326567787 FDA UDI
510(k) Number
K220143 FDA UDI
FDA Product Code
LPL FDA UDI
MVN FDA UDI
GMDN Term
Soft corrective contact lens, daily-disposable FDA UDI
Models / Variants
Unicoeye FDA UDI
BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
886.5925 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Soft corrective contact lens, daily-disposable

Unicoeye +1 more model by Shenzhen Dashicheng Optical Technology Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — 2 models — regulatory data on deviCERTS

Similar devices

Also classified as Soft corrective contact lens, daily-disposable.

Cleared under the same submission

K220143 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Shenzhen Dashicheng Optical Technology Co., Ltd.

Sources (1)

  • FDA UDI d9105a1a-a341-4f51-a4bc-9e4257431a7d 34 fields · synced May 31, 2026