FDA 510(k)

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

K-Number: K240095 · 2024-10-09

ApplicantShanghai Care US Medical Product Co., Ltd.

Decision Date2024-10-09

Product CodeLRX

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.