FDA 510(k) Application Details - K182215

Device Classification Name	Light, Ultraviolet, Dermatological   More FDA Info for this Device
510(K) Number	K182215
Device Name	Light, Ultraviolet, Dermatological
Applicant	Daavlin Distributing Company 205 W. Bement Street Bryan, OH 43506 US Other 510(k) Applications for this Company
Contact	Michele Thiel Other 510(k) Applications for this Contact
Regulation Number	878.4630   More FDA Info for this Regulation Number
Classification Product Code	FTC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/15/2018
Decision Date	10/29/2018
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