FDA 510(k)

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

Numéro K : K240095 · 2024-10-09

DemandeurShanghai Care US Medical Product Co., Ltd.

Date de décision2024-10-09

Code produitLRX

Comité consultatifOP

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

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Dispositifs connexes (Code : 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

Source officielle

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