FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
Ultravision2 IonPencil
K Number: K240868
·
Decision Aug 12, 2024
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
6
Applicant Total
1
Review Days
136
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Basic Information
- Device Name
- Ultravision2 IonPencil
- K Number
- K240868
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.5050
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Alesi Surgical Limited
- Date Received
- March 29, 2024
- Decision Date
- August 12, 2024
- Product Code
- PQM
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| PQM | Surgical Smoke Precipitator | FDA class 2 | General, Plastic Surgery |
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