DeviceClearance

Confocal Microprobe Imaging System (10 models)— 510(k) K243711

Substantially Equivalent

Wuxi Hisky Medical Technologies Co., Ltd.

FDA 510(k) clearance K243711 for Confocal Microprobe Imaging System (10 models), Substantially Equivalent on 2025-07-24. Applicant: Wuxi Hisky Medical Technologies Co., Ltd.. Device class: 2.

Clearance details

Device name as filed
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.
Product code
Code OWN
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Wuxi, CN
Download summary PDFView on FDA.gov ↗

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Adverse events under product code OWN

product code OWN
Malfunction
1,286
Total
1,286

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.