FDA 510(k) Application Details - K241116

Device Classification Name	More FDA Info for this Device
510(K) Number	K241116
Device Name	Onycho Laser V
Applicant	TerasysD&C Inc. Unit 1101~1108, Building N, 249 Sunhwagung-ro, Namyangju-si Gyeonggi-do 12106 KR Other 510(k) Applications for this Company
Contact	Sanghyeop Han Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PDZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/23/2024
Decision Date	07/22/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review