FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AuraGen 123 Suction Lipoplasty System (A123)
K Number: K190278
·
Decision May 3, 2019
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
39
Applicant Total
1
Review Days
84
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Basic Information
- Device Name
- AuraGen 123 Suction Lipoplasty System (A123)
- K Number
- K190278
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.5040
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Auragen Aesthetics, LLC
- Date Received
- February 8, 2019
- Decision Date
- May 3, 2019
- Product Code
- MUU
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| MUU | System, Suction, Lipoplasty | FDA class 2 | General, Plastic Surgery |
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