FDA 510(k) Application Details - K243654

Device Classification Name	Refrigerant, Topical (Vapocoolant)   More FDA Info for this Device
510(K) Number	K243654
Device Name	Refrigerant, Topical (Vapocoolant)
Applicant	Vapocoolshot, Inc 950 Peninsula Corporate Circle Suite 2011 Boca Raton, FL 33487 US Other 510(k) Applications for this Company
Contact	Jacob Leibovici Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	MLY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/26/2024
Decision Date	05/30/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review