FDA 510(k) Application Details - K202998

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K202998
Device Name	Powered Laser Surgical Instrument
Applicant	Vydence Medical Industria E Comercio Ltda Rua Aldo Germano Klein, 359 CEP: 13.573-470 - Caixa Postal 772 CEAT - Sao Carlos/SP Sao Paulo 13.573-470 BR Other 510(k) Applications for this Company
Contact	Kathy Maynor 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	10/01/2020
Decision Date	10/26/2021
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