FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Venus Versa System
K Number: K153717
·
Decision Mar 21, 2016
Classifications
1
FEI Numbers
92
Registration Numbers
93
Same Product Code
73
Applicant Total
9
Review Days
88
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Basic Information
- Device Name
- Venus Versa System
- K Number
- K153717
- 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
- Venus Concept , Ltd.
- Date Received
- December 24, 2015
- Decision Date
- March 21, 2016
- Product Code
- ONF
- 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 |
|---|---|---|---|
| ONF | Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Venus Concept , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K162765 | Venus Velocity Diode Laser System | Jan 11, 2017 | Substantially Equivalent |
| K152790 | Venus Versa System | Jan 20, 2016 | Substantially Equivalent |
| K143554 | Venus Legacy CX | Aug 4, 2015 | Substantially Equivalent |
| K150161 | Venus Viva SR Device | May 12, 2015 | Substantially Equivalent |
| K140629 | VENUS SWAN(MP)2 | Jun 25, 2014 | Substantially Equivalent |
| K111670 | VENUS FREEZE (MP)2 SYSTEM | Mar 2, 2012 | Substantially Equivalent |
| K111784 | VENUS SWAN SYSTEM | Oct 7, 2011 | Substantially Equivalent |
| K100586 | VENUS FREEZE SYSTEM | Nov 29, 2010 | Substantially Equivalent |