FDA 510(k) Application Details - K213629

Device Classification Name	More FDA Info for this Device
510(K) Number	K213629
Device Name	SMILE
Applicant	Nu Eyne Co., Ltd. #608, 28, Digital-ro 30-gil, Guro-gu Seoul 08389 KR Other 510(k) Applications for this Company
Contact	Dong Seong Lee Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QGL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/17/2021
Decision Date	02/12/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review