Moody; BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens

GUDID 06975326561501

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.

Shenzhen Dashicheng Optical Technology Co., Ltd.

Soft corrective contact lens, daily-wear
Primary Device ID06975326561501
NIH Device Record Key74140faf-d3a3-4a91-823b-1090513e876f
Commercial Distribution StatusIn Commercial Distribution
Brand NameMoody; BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens
Version Model NumberBARBIE
Company DUNS543028405
Company NameShenzhen Dashicheng Optical Technology Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106975326561501 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LPLLenses, Soft Contact, Daily Wear

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-27
Device Publish Date2023-06-19

Devices Manufactured by Shenzhen Dashicheng Optical Technology Co., Ltd.

06975326561525 - Miiemo; BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens2024-10-22 BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens are indicated for the correction of visual acuity in aphakic and n
06975326564298 - color contact lens, BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Len2024-03-19 BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens are indicated for the correction of visual acuity in aphakic and n
06975326564304 - color contact lens, BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Len2024-03-19 BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens are indicated for the correction of visual acuity in aphakic and n
06975326561501 - Moody; BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens2023-06-27BARBIE (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.
06975326561501 - Moody; BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens2023-06-27 BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens are indicated for the correction of visual acuity in aphakic and n
06975326560979 - Lensweets; BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens2023-05-30 BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens are indicated for the correction of visual acuity in aphakic and n
06975326561051 - Miiemo; BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens2023-05-30 BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens are indicated for the correction of visual acuity in aphakic and n
06975326561259 - Unicoeye; BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens2023-05-30 BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens are indicated for the correction of visual acuity in aphakic and n
06975326567763 - Lensweets; BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens2023-05-30 BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens are indicated for the correction of visual acuity in aphakic and n

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