FDA 510(k) Application Details - K190392

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K190392
Device Name	Powered Laser Surgical Instrument
Applicant	Alcon Laboratories, Inc. 20511 Lake Forest Drive Lake Forest, CA 92630 US Other 510(k) Applications for this Company
Contact	Ophelia Biggs Other 510(k) Applications for this Contact
Regulation Number	878.4810   More FDA Info for this Regulation Number
Classification Product Code	GEX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/19/2019
Decision Date	03/26/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review