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

About This 510(k) Submission

K240095 is an FDA 510(k) clearance for the CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6), a Case, Contact Lens (Class II — Special Controls, product code LRX), submitted by Shanghai Care US Medical Product Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on October 9, 2024, 271 days after receiving the submission on January 12, 2024. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5928.