FDA 510(k) Application Details - K243027

Device Classification Name	More FDA Info for this Device
510(K) Number	K243027
Device Name	Disposable Aqueous Humor Collector (SnovoDAHC I-50, SnovoDAHC II-50, SnovoDAHC II-50-27, SnovoDAHC II-100-27)
Applicant	Hangzhou Sightnovo Medical Technology Co., Ltd. 101M, Building 7, No. 22, Xinyan Road, Yuhang Economic and Technological Development Zone, Yuhang District, Hangzhou Hangzhou City 311100 CN Other 510(k) Applications for this Company
Contact	Eric Shi Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QLY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/27/2024
Decision Date	04/08/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review