FDA 510(k) Application Details - K240512

Device Classification Name	More FDA Info for this Device
510(K) Number	K240512
Device Name	Tixel i (TXLI0001)
Applicant	Novoxel Ltd. 43 Hamelaha St. Netanya 4250573 IL Other 510(k) Applications for this Company
Contact	Daniela Dov Elmaz Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	ORZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/22/2024
Decision Date	11/04/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review