FDA 510(k) Application Details - K222205

Device Classification Name	More FDA Info for this Device
510(K) Number	K222205
Device Name	Cold Sore Device (Model: QPZ-01)
Applicant	Light Tree Ventures Europe B.V. Laan van Ypenburg 108, 2497 GC, The Hague, The Netherlands Hague NL Other 510(k) Applications for this Company
Contact	Alain Dijkstra Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OKJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/25/2022
Decision Date	10/07/2022
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