FDA.reportPublic FDA data

510(k) K243711

Device
Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System (BrightP960); Confocal Microprobe Imaging System (BrightP880); Confocal Microprobe Imaging System (BrightP860); Confocal Microprobe Imaging System (BrightP780); Confo
Applicant
Wuxi Hisky Medical Technologies Co., Ltd.
510(k) number
K243711
Product code
OWN
Decision
Substantially Equivalent (SESE)
Decision date
2025-07-24
Date received
2024-12-02
Regulation
876.1500
Classification name
Confocal Optical Imaging
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Jinhua Shao
Address
Rm. B401, 530 Plz., University Science Park, Taihu Internati Wuxi CN 214135 214135

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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