510(k) K262097
K262097 is an FDA 510(k) premarket notification submitted by Carl Zeiss Meditec Cataract Technologies for the device "MICOR 700 System (N/A); MICOR 700 Extractor (FG-50621)". The FDA issued a decision of Substantially Equivalent on Oct 15, 2026. The device falls under product code HQC (Unit, Phacofragmentation), a Class II device regulated under 21 CFR 886.4670.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 15, 2026
- Date Received
- Jun 22, 2026
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Phacofragmentation
- Device Class
- Class II
- Regulation Number
- 886.4670
- Review Panel
- OP
- Submission Type
- 510(k)