CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6)
FDA 510(k) clearance K240095 · decided 2024-10-09
Clearance details
- K-number
- K240095
- Device name
- CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6)
- Applicant
- Shanghai Care US Medical Product Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2024-01-12
- Decision date
- 2024-10-09
- Days to decision
- 271 days
- Clearance type
- Traditional
- Product code
- LRX
- Device class
- 2
- Regulation number
- 886.5928
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Shanghai, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.