FDA 510(k) Application Details - K242098

Device Classification Name	System, Imaging, Optical Coherence Tomography (Oct)   More FDA Info for this Device
510(K) Number	K242098
Device Name	System, Imaging, Optical Coherence Tomography (Oct)
Applicant	Shenzhen Vivolight Medical Device & Technology Co., Ltd. Room 511-A, 5th Floor, Block B, Building R2, High-Tech Indus strial Park, No. 020, South Seventh Road Gaoxin Community, Shenzhen 518055 CN Other 510(k) Applications for this Company
Contact	Gao Pengyang Other 510(k) Applications for this Contact
Regulation Number	892.1560   More FDA Info for this Regulation Number
Classification Product Code	NQQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/18/2024
Decision Date	04/11/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review