FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
T-SHAPE 2
K Number: K231092
·
Decision Sep 22, 2023
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
18
Applicant Total
1
Review Days
157
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Basic Information
- Device Name
- T-SHAPE 2
- K Number
- K231092
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- B&M S.R.L. Marketing Nel Benessere
- Date Received
- April 18, 2023
- Decision Date
- September 22, 2023
- Product Code
- NUV
- 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 |
|---|---|---|---|
| NUV | Massager, Vacuum, Light Induced Heating | FDA class 2 | General, Plastic Surgery |
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