510(k) K240095
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