FDA 510(k) Application Details - K233295

Device Classification Name	More FDA Info for this Device
510(K) Number	K233295
Device Name	LFR-260
Applicant	Evolution Optiks Limited Pasea Financial Centre Corner Harts Gap & Dayrells Road Christ Church BB14030 BB Other 510(k) Applications for this Company
Contact	Raul Mihali Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	SBI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/29/2023
Decision Date	05/31/2024
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