Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS)
FDA 510(k) clearance K240297 · decided 2024-05-03
Clearance details
- K-number
- K240297
- Device name
- Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS)
- Applicant
- Us Medical Innovations, LLC
- Decision
- Substantially Equivalent
- Date received
- 2024-02-01
- Decision date
- 2024-05-03
- Days to decision
- 92 days
- Clearance type
- Traditional
- Product code
- OAB
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Tacoma Park, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.