miCOR System Lens Fragmentation System
FDA 510(k) clearance K222236 · decided 2022-08-24
Clearance details
- K-number
- K222236
- Device name
- miCOR System Lens Fragmentation System
- Applicant
- Carl Zeiss Meditec Cataract Technology, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-07-26
- Decision date
- 2022-08-24
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- HQC
- Device class
- 2
- Regulation number
- 886.4670
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Reno, NV, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.