FDA 510(k) Application Details - K232177

Device Classification Name	More FDA Info for this Device
510(K) Number	K232177
Device Name	Lightin System, Lightin, Lightin Generator
Applicant	Solmedix Co., Ltd #706, 330, Seongarm-ro, Mapo-gu Seoul 03920 KR Other 510(k) Applications for this Company
Contact	Hyeroung Lee Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	SBS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/24/2023
Decision Date	07/10/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review