510(k) K230858
K230858 is an FDA 510(k) premarket notification submitted by Carl Zeiss Meditec, AG for the device "QUATERA 700". The FDA issued a decision of Substantially Equivalent on July 31, 2023. The device falls under product code HQC (Unit, Phacofragmentation), a Class II device regulated under 21 CFR 886.4670. Carl Zeiss Meditec, AG has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 31, 2023
- Date Received
- March 29, 2023
- Clearance Type
- Traditional
- 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