General_plastic_surgery
Co-Ablation System with Sterile Co-Ablation Probe
Hygea Medical Technology Co., Ltd.
FDA
FDA-cleared AI medical device
FDA Submission Metadata
- Submission number
- K243042
- Decision date
- January 2025
- FDA panel
- General and Plastic Surgery
- Product code
- GEH
This entry is sourced from the FDA AI/ML-Enabled Medical Devices list. No editorial review yet — the catalogue may add a deeper review of this device in future.
Regulatory Approvals
FDA
US FDA 510k
K243042
This entry is on our editorial review queue. Full evaluation — performance metrics, clinical evidence, safety record — lands as our review pipeline graduates each device. The information above is what's been verified to date.