FDA 510(k) Application Details - DEN180008

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN180008
Device Name	MolecuLight i:X
Applicant	MolecuLight Inc. 101 College St. Suite 200 Toronto M5G 1L7 CA Other 510(k) Applications for this Company
Contact	Jeffrey K. Shapiro Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QCR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/16/2018
Decision Date	07/31/2018
Decision	DENG -
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review