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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Confocal Optical Imaging
510(k) Number K243711
Device Name 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); Confocal Microprobe Imaging System (BrightP750); Confocal Microprobe Imaging System (BrightP680); Confocal Microprobe Imaging System (BrightP660); Confocal Microprobe Imaging System (BrightP600); Confocal Microprobe Imaging System (BrightP580);
Applicant
Wuxi Hisky Medical Technologies Co., Ltd.
Rm. B401, 530 Plz., University Science Park, Taihu Internati
Wuxi,  CN 214135
Applicant Contact Jinhua Shao
Correspondent
Pureid Medical Technology Co., Ltd.
111 Town Sq. Pl.
Suite 1203
Jersey City,  NJ  07310
Correspondent Contact Jarvis Wu
Regulation Number876.1500
Classification Product Code
OWN  
Date Received12/02/2024
Decision Date 07/24/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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