FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Profound System
K Number: K161043
·
Decision Sep 12, 2016
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
77
Applicant Total
5
Review Days
152
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Basic Information
- Device Name
- Profound System
- K Number
- K161043
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Syneron Candela Corporation
- Date Received
- April 13, 2016
- Decision Date
- September 12, 2016
- Product Code
- PBX
- 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 |
|---|---|---|---|
| PBX | Massager, Vacuum, Radio Frequency Induced Heat | FDA class 2 | General, Plastic Surgery |
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