K243711
- 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. CN
- Product code
- OWN — Confocal Optical Imaging
- Decision date
- 2025-07-24
- Date received
- 2024-12-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K243711.pdf
Official FDA record: K243711
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.