510(k) K240095

CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6) by Shanghai Care US Medical Product Co., Ltd. — Product Code LRX

K240095 is an FDA 510(k) premarket notification submitted by Shanghai Care US Medical Product Co., Ltd. for the device "CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6)". The FDA issued a decision of Substantially Equivalent on October 9, 2024. The device falls under product code LRX (Case, Contact Lens), a Class II device regulated under 21 CFR 886.5928.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 9, 2024
Date Received
January 12, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Case, Contact Lens
Device Class
Class II
Regulation Number
886.5928
Review Panel
OP
Submission Type