FDA 510(k)

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

Номер K: K220143 · 2022-09-08

ЗаявительShenzhen Dashicheng Optical Technology Co., Ltd.

Дата решения2022-09-08

Код продуктаLPL

Консультативный комитетOP

РешениеSubstantially Equivalent

Описание устройства

BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Dashicheng Optical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-09-08 under 510(k) number K220143. The device is classified under product code LPL. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens?

BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens is a medical device that received FDA 510(k) clearance on 2022-09-08. The listed applicant is Shenzhen Dashicheng Optical Technology Co., Ltd.. The 510(k) number is K220143.

When did BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens receive FDA 510(k) clearance?

BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens received FDA 510(k) clearance on 2022-09-08, under 510(k) number K220143.

Who is the listed applicant for BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens?

The FDA 510(k) record lists Shenzhen Dashicheng Optical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens?

The FDA product code for BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens is LPL.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: LPL)

Официальный источник

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