FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Avéli
K Number: K232153
·
Decision Aug 18, 2023
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
8
Applicant Total
2
Review Days
30
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Basic Information
- Device Name
- Avéli
- K Number
- K232153
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.4790
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Revelle Aesthetics, Inc.
- Date Received
- July 19, 2023
- Decision Date
- August 18, 2023
- Product Code
- OUP
- 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 |
|---|---|---|---|
| OUP | Powered Surgical Instrument For Improvement In The Appearance Of Cellulite | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OUP), ordered by most recent decision date.
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Other Clearances by Revelle Aesthetics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K221336 | Avéli | Aug 5, 2022 | Substantially Equivalent |