Miiemo - Miiemo

FDA UDI

Class II (US FDA UDI)

by Shenzhen Dashicheng Optical Technology Co., Ltd.

Identity

Trade Name: Miiemo; BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens FDA UDI
Generic Name: Soft corrective contact lens, daily-wear 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. 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. 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. 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. FDA UDI

Identifiers

Primary DI / UDI-DI: 06975326561051 FDA UDI
510(k) Number: K220143 FDA UDI
FDA Product Code: LPL FDA UDI
MVN FDA UDI
GMDN Term: Soft corrective contact lens, daily-wear FDA UDI
Models / Variants: Miiemo 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

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Soft corrective contact lens, daily-wear

Miiemo - Miiemo by Shenzhen Dashicheng Optical Technology Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — 2 models — regulatory data on deviCERTS

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

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HAPA KRISTIN — INTEROJO INC. · Class II
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ArtMost SoftOK Daily Wear Soft Contact Lens — SEINOH OPTICAL CO., LTD. · Class II

Cleared under the same submission

K220143 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Shenzhen Dashicheng Optical Technology Co., Ltd.

Sources (1)

FDA UDI 4835084e-0203-48cb-8682-4bba82edb1ba 34 fields · synced Jun 8, 2026