FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
BeShape One Device
K Number: K231628
·
Decision Sep 29, 2023
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
29
Applicant Total
1
Review Days
116
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Basic Information
- Device Name
- BeShape One Device
- K Number
- K231628
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4590
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Beshape Technologies , Ltd.
- Date Received
- June 5, 2023
- Decision Date
- September 29, 2023
- Product Code
- OHV
- 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 |
|---|---|---|---|
| OHV | Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption | FDA class 2 | General, Plastic Surgery |
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