FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
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);
K Number: K243711
·
Decision Jul 24, 2025
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
60
Applicant Total
5
Review Days
234
Basic Information
- 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);
- K Number
- K243711
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Wuxi Hisky Medical Technologies Co., Ltd.
- Date Received
- December 2, 2024
- Decision Date
- July 24, 2025
- Product Code
- OWN
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OWN | Confocal Optical Imaging | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Wuxi Hisky Medical Technologies Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K250026 | Shear Wave Quantificational Ultrasound Diagnostic System (FH9000/FH7000/FH6000/FH5000/FH3000/FH1000) | Oct 1, 2025 | Substantially Equivalent |
| K243880 | Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800, Mini790, Mini780, Mini560, Mini300, Mini100, FT100) | Jun 17, 2025 | Substantially Equivalent |
| K200136 | Shear Wave Quantificational Ultrasound Diagnostic System | Mar 17, 2020 | Substantially Equivalent |
| K173595 | Shear Wave Quantificational Ultrasound Diagnostic System | Jun 22, 2018 | Substantially Equivalent |