FDA 510(k) Application Details - K250384

Device Classification Name	Light Based Over-The-Counter Hair Removal   More FDA Info for this Device
510(K) Number	K250384
Device Name	Light Based Over-The-Counter Hair Removal
Applicant	EL Global Trade Ltd Gibore Israel 13 Netanya 42407 IL Other 510(k) Applications for this Company
Contact	Stephanie Khoury Other 510(k) Applications for this Contact
Regulation Number	878.4810   More FDA Info for this Regulation Number
Classification Product Code	OHT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/11/2025
Decision Date	05/23/2025
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