FDA 510(k) Application Details - K242801

Device Classification Name	Unit, Phacofragmentation   More FDA Info for this Device
510(K) Number	K242801
Device Name	Unit, Phacofragmentation
Applicant	Carl Zeiss Meditec Cataract Technology Inc. 8740 Technology Way Reno, NV 89521 US Other 510(k) Applications for this Company
Contact	Andrew Rybold Other 510(k) Applications for this Contact
Regulation Number	886.4670   More FDA Info for this Regulation Number
Classification Product Code	HQC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/17/2024
Decision Date	06/11/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review