FDA 510(k) Application Details - K242389

Device Classification Name	Folders And Injectors, Intraocular Lens (Iol)   More FDA Info for this Device
510(K) Number	K242389
Device Name	Folders And Injectors, Intraocular Lens (Iol)
Applicant	Bausch & Lomb Incorporated 1400 North Goodman Street Rochester, NY 14609 US Other 510(k) Applications for this Company
Contact	Renee Stoffel Other 510(k) Applications for this Contact
Regulation Number	886.4300   More FDA Info for this Regulation Number
Classification Product Code	MSS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/12/2024
Decision Date	10/10/2024
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