FDA 510(k) Application Details - K233876

Device Classification Name	Unit, Phacofragmentation   More FDA Info for this Device
510(K) Number	K233876
Device Name	Unit, Phacofragmentation
Applicant	Alcon Laboratories Inc. 6201 South Freeway Fort Worth, TX 76134 US Other 510(k) Applications for this Company
Contact	Ganesh Balachandar 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	12/07/2023
Decision Date	06/21/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review