FDA 510(k) Application Details - K233766

Device Classification Name	More FDA Info for this Device
510(K) Number	K233766
Device Name	Geneo X Elite
Applicant	Pollogen Ltd. 6 Kaufman St. POB 50320 Tel-Aviv 6801298 IL Other 510(k) Applications for this Company
Contact	Karen Smith Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PAY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/24/2023
Decision Date	05/07/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review