FDA 510(k) Application Details - K201623

Device Classification Name	Laser, Ophthalmic   More FDA Info for this Device
510(K) Number	K201623
Device Name	Laser, Ophthalmic
Applicant	Norlase ApS Brydehusvej 30 2750 Ballerup DK Other 510(k) Applications for this Company
Contact	Jan Forstberg Other 510(k) Applications for this Contact
Regulation Number	886.4390   More FDA Info for this Regulation Number
Classification Product Code	HQF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/15/2020
Decision Date	08/11/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review