K242801
- 510(k) number
- K242801
- Device name
- MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185)
- Applicant
- Carl Zeiss Meditec Cataract Technology, Inc. NV · US
- Product code
- HQC — Unit, Phacofragmentation
- Decision date
- 2025-06-11
- Date received
- 2024-09-17
- 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: K242801
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.