FDA 510(k) Application Details - K233962

Device Classification Name	More FDA Info for this Device
510(K) Number	K233962
Device Name	ReBorn (1050nm)
Applicant	LightFective Ltd. 2 Hatochen Str. Caesarea 3079533 IL Other 510(k) Applications for this Company
Contact	Tsvi Bahat Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PKT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/15/2023
Decision Date	04/16/2024
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