FDA 510(k)

TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)

Номер K: K220045 · 2022-08-05

Дата решения2022-08-05

Код продуктаLPL

Консультативный комитетOP

РешениеSubstantially Equivalent

Описание устройства

TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) is the device name listed in this FDA 510(k) record. The listed applicant is Dk Medivision Co., Ltd.. It received FDA 510(k) clearance on 2022-08-05 under 510(k) number K220045. 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 TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)?

TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) is a medical device that received FDA 510(k) clearance on 2022-08-05. The listed applicant is Dk Medivision Co., Ltd.. The 510(k) number is K220045.

When did TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) receive FDA 510(k) clearance?

TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) received FDA 510(k) clearance on 2022-08-05, under 510(k) number K220045.

Who is the listed applicant for TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)?

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

What is the FDA product code for TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)?

The FDA product code for TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Связанные устройства (Код: LPL)

Официальный источник

Посмотреть в базе данных FDA →

Данные получены из открытого API FDA. Для получения наиболее актуальной и авторитетной информации всегда обращайтесь к официальным записям.