FDA 510(k) Application Details - K213840

Device Classification Name	More FDA Info for this Device
510(K) Number	K213840
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	Jordan John 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	12/09/2021
Decision Date	05/18/2022
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