FDA 510(k) Application Details - K243896

Device Classification Name	Ophthalmic Femtosecond Laser   More FDA Info for this Device
510(K) Number	K243896
Device Name	Ophthalmic Femtosecond Laser
Applicant	Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, TX 76134-2099 US Other 510(k) Applications for this Company
Contact	Tammy Vu Other 510(k) Applications for this Contact
Regulation Number	886.4390   More FDA Info for this Regulation Number
Classification Product Code	OOE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/18/2024
Decision Date	04/28/2025
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