FDA 510(k)

3N Contact Lenses Adjunct Cleaner

Номер K: K211361 · 2022-01-13

ЗаявительSuzhou 3N Biological Technology Co., Ltd.

Дата решения2022-01-13

Код продуктаLYL

Консультативный комитетOP

РешениеSubstantially Equivalent

Описание устройства

3N Contact Lenses Adjunct Cleaner is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou 3N Biological Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-01-13 under 510(k) number K211361. The device is classified under product code LYL. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the 3N Contact Lenses Adjunct Cleaner?

3N Contact Lenses Adjunct Cleaner is a medical device that received FDA 510(k) clearance on 2022-01-13. The listed applicant is Suzhou 3N Biological Technology Co., Ltd.. The 510(k) number is K211361.

When did 3N Contact Lenses Adjunct Cleaner receive FDA 510(k) clearance?

3N Contact Lenses Adjunct Cleaner received FDA 510(k) clearance on 2022-01-13, under 510(k) number K211361.

Who is the listed applicant for 3N Contact Lenses Adjunct Cleaner?

The FDA 510(k) record lists Suzhou 3N Biological Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3N Contact Lenses Adjunct Cleaner?

The FDA product code for 3N Contact Lenses Adjunct Cleaner is LYL.

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: LYL)

K210300VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning SystemVuesonic, LLC

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.