FDA 510(k) Application Details - K240169

Device Classification Name	Unit, Phacofragmentation   More FDA Info for this Device
510(K) Number	K240169
Device Name	Unit, Phacofragmentation
Applicant	Bausch and Lomb Incorporated 3365 Tree Court Industrial Boulevard St. Louis, MO 63122 US Other 510(k) Applications for this Company
Contact	Ken Nehmer 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	01/22/2024
Decision Date	07/26/2024
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