510(k) K222236

miCOR System Lens Fragmentation System by Carl Zeiss Meditec Cataract Technology, Inc. — Product Code HQC

K222236 is an FDA 510(k) premarket notification submitted by Carl Zeiss Meditec Cataract Technology, Inc. for the device "miCOR System Lens Fragmentation System". The FDA issued a decision of Substantially Equivalent on August 24, 2022. 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 24, 2022
Date Received
July 26, 2022
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