FDA 510(k) Application Details - K172439

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K172439
Device Name	Powered Laser Surgical Instrument
Applicant	Vydence Rua Aldo Germano Klein, 359 Cep: 13.573-470 - Caixa Postal 772 Sao Carlos/ Sp Sao Paulo 13.573-470 BR Other 510(k) Applications for this Company
Contact	Kevin Walls 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	08/11/2017
Decision Date	02/14/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review