FDA 510(k) Application Details - K182453

Device Classification Name	Massager, Vacuum, Light Induced Heating   More FDA Info for this Device
510(K) Number	K182453
Device Name	Massager, Vacuum, Light Induced Heating
Applicant	I-TECH INDUSTRIES SRL Via Cicogna 34/b San Lazzaro di Savena 40068 IT Other 510(k) Applications for this Company
Contact	Paolo Abbreviato Other 510(k) Applications for this Contact
Regulation Number	878.4810   More FDA Info for this Regulation Number
Classification Product Code	NUV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/07/2018
Decision Date	01/11/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review