FDA 510(k)

EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear

Номер K: K161124 · 2016-08-26

Дата решения2016-08-26

Код продуктаLPL

Консультативный комитетOP

РешениеSubstantially Equivalent

Описание устройства

EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear is the device name listed in this FDA 510(k) record. The listed applicant is Vision Science Co., Ltd.. It received FDA 510(k) clearance on 2016-08-26 under 510(k) number K161124. 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 EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear?

EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear is a medical device that received FDA 510(k) clearance on 2016-08-26. The listed applicant is Vision Science Co., Ltd.. The 510(k) number is K161124.

When did EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear receive FDA 510(k) clearance?

EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear received FDA 510(k) clearance on 2016-08-26, under 510(k) number K161124.

Who is the listed applicant for EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear?

The FDA 510(k) record lists Vision Science Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear?

The FDA product code for EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear 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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