K243395
- 510(k) number
- K243395
- Device name
- MICOR 700 with Auto I/A
- Applicant
- Carl Zeiss Meditec Cataract Technology, Inc. NV · US
- Product code
- HQC — Unit, Phacofragmentation
- Decision date
- 2025-08-08
- Date received
- 2024-10-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ophthalmic
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K243395
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.