FDA 510(k) Application Details - K200724

Device Classification Name	Ophthalmic Femtosecond Laser   More FDA Info for this Device
510(K) Number	K200724
Device Name	Ophthalmic Femtosecond Laser
Applicant	Technolas Perfect Vision GmbH Messerschmittstr. 1 + 3 Munich 80992 DE Other 510(k) Applications for this Company
Contact	Friedrich Moritz 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	03/19/2020
Decision Date	09/01/2020
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