FDA 510(k) Application Details - DEN200028

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN200028
Device Name	Lumenis Stellar M22
Applicant	Lumenis Ltd. 6 Hakidma Street PO Box 240 Yokneam 2069204 IL Other 510(k) Applications for this Company
Contact	Shlomit Segman Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QIU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/20/2020
Decision Date	02/23/2021
Decision	DENG -
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review