FDA 510(k) Application Details - K191962

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K191962
Device Name	Powered Laser Surgical Instrument
Applicant	Quantel Medical 11 Rue du Bois Joli-CS40015 Cournon D'Auvergne-Cedex 63808 FR Other 510(k) Applications for this Company
Contact	Bruno Pages Other 510(k) Applications for this Contact
Regulation Number	878.4810   More FDA Info for this Regulation Number
Classification Product Code	GEX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/23/2019
Decision Date	12/05/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review