FDA 510(k)

CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6)

Номер K: K240095 · 2024-10-09

ЗаявительShanghai Care US Medical Product Co., Ltd.

Дата решения2024-10-09

Код продуктаLRX

Консультативный комитетOP

РешениеSubstantially Equivalent

Описание устройства

CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6) is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Care US Medical Product Co., Ltd.. It received FDA 510(k) clearance on 2024-10-09 under 510(k) number K240095. The device is classified under product code LRX. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6)?

CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6) is a medical device that received FDA 510(k) clearance on 2024-10-09. The listed applicant is Shanghai Care US Medical Product Co., Ltd.. The 510(k) number is K240095.

When did CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6) receive FDA 510(k) clearance?

CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6) received FDA 510(k) clearance on 2024-10-09, under 510(k) number K240095.

Who is the listed applicant for CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6)?

The FDA 510(k) record lists Shanghai Care US Medical Product Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6)?

The FDA product code for CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6) is LRX.

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: LRX)

K252175LANDR Contact LENS CaseFourth Axis, LLC K250495MINI VP1 (PL67_F); MINI VP1 (PL61_F)Avizor S.A.K231123Phoenix Contact Lens Case - dome top flat pack (CL-01); Phoenix Contact Lens Case - classic flat pack (CL-02); Phoenix Contact Lens Case - sunglass shape flat pack (CL-03)Phoenix Innovative Healthcare Manufacturers Pvt. , Ltd.K173538Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODiscAlcon Laboratories, Inc.K172925Contact Lens Case, Model: A-1, B-1P L Overseas Limited K173365Bausch + Lomb Boston Scleral Lens CaseBausch & Lomb, Incorporated

Официальный источник

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