FDA 510(k) Application Details - K243555

Device Classification Name	Over-The-Counter Powered Light Based Laser For Acne   More FDA Info for this Device
510(K) Number	K243555
Device Name	Over-The-Counter Powered Light Based Laser For Acne
Applicant	Shenzhen Eyco Technology Co., Ltd 2 /F, Building 1, Jiashitai Science Park, 164# Fengtang Ave Fuhai Street, Baoan District, Shenzhen 518103, China Guangdong 518103 CN Other 510(k) Applications for this Company
Contact	Ding Martin Other 510(k) Applications for this Contact
Regulation Number	878.4810   More FDA Info for this Regulation Number
Classification Product Code	OLP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/18/2024
Decision Date	02/05/2025
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