FDA 510(k)

PuriLens Plus Preservative Free Saline

Номер K: K200747 · 2020-05-15

Дата решения2020-05-15

Код продуктаLPN

Консультативный комитетOP

РешениеSubstantially Equivalent

Описание устройства

PuriLens Plus Preservative Free Saline is the device name listed in this FDA 510(k) record. The listed applicant is The Lifestyle Company, Inc.. It received FDA 510(k) clearance on 2020-05-15 under 510(k) number K200747. The device is classified under product code LPN. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the PuriLens Plus Preservative Free Saline?

PuriLens Plus Preservative Free Saline is a medical device that received FDA 510(k) clearance on 2020-05-15. The listed applicant is The Lifestyle Company, Inc.. The 510(k) number is K200747.

When did PuriLens Plus Preservative Free Saline receive FDA 510(k) clearance?

PuriLens Plus Preservative Free Saline received FDA 510(k) clearance on 2020-05-15, under 510(k) number K200747.

Who is the listed applicant for PuriLens Plus Preservative Free Saline?

The FDA 510(k) record lists The Lifestyle Company, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PuriLens Plus Preservative Free Saline?

The FDA product code for PuriLens Plus Preservative Free Saline is LPN.

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: LPN)

K253795MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting SolutionMenicon Co, Ltd.K222541Bausch + Lomb Preservative Free Lubricating and Rewetting DropsBausch & Lomb, Incorporated K221263Aqua Naina Plus Sterile Saline SolutionChemtex USA, Inc.K202932ABT12 многофункциональный растворBausch & Lomb, Incorporated K210051OTE MPS 045 Multi-purpose Lens Care SolutionOte North America, LLC K193441Aqua Naina Sterile Saline SolutionChemtex USA, Inc.

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.