510(k) K191024
K191024 is an FDA 510(k) premarket notification submitted by Carl Zeiss Meditec Cataract Technology, Inc. for the device "xPORT Lens Fragmentation System". The FDA issued a decision of Substantially Equivalent on August 13, 2019. The device falls under product code HQC (Unit, Phacofragmentation), a Class II device regulated under 21 CFR 886.4670. Carl Zeiss Meditec Cataract Technology, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 13, 2019
- Date Received
- April 18, 2019
- 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