FDA 510(k) Application Details - K191371

Device Classification Name	More FDA Info for this Device
510(K) Number	K191371
Device Name	MolecuLight i:X
Applicant	MolecuLight Inc. Suite 700, 425 University Avenue Toronto M5G 1T6 CA Other 510(k) Applications for this Company
Contact	Anil Amlani Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QJF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/22/2019
Decision Date	12/04/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review