510(k) K243711 ยท OWN Confocal Optical Imaging
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); Confoc
| Applicant | Wuxi Hisky Medical Technologies Co., Ltd., Wuxi, CN |
| Decision | Substantially Equivalent, Jul 24, 2025 |
| Received | Dec 2, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243711
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.