FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
V30 system, V20 system, V10 system, V-VR Hand piece
K Number: K202247
·
Decision Dec 9, 2020
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
77
Applicant Total
11
Review Days
121
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Basic Information
- Device Name
- V30 system, V20 system, V10 system, V-VR Hand piece
- K Number
- K202247
- 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
- Viora , Ltd.
- Date Received
- August 10, 2020
- Decision Date
- December 9, 2020
- 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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Other Clearances by Viora , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K201064 | V30 System, V20 System, V10 System, V-FR Handpiece | Jul 15, 2020 | Substantially Equivalent |
| K200468 | V30 system, V20 system, V10 system, V-FC Handpiece | May 21, 2020 | Substantially Equivalent |
| K162363 | V30 system, V-Form Handpiece BC Medium applicator | Nov 18, 2016 | Substantially Equivalent |
| K152611 | V20 system | Feb 19, 2016 | Substantially Equivalent |
| K150035 | V10 system | May 1, 2015 | Substantially Equivalent |
| K142093 | V20 SYSTEM | Nov 14, 2014 | Substantially Equivalent |
| K141904 | VIORA V-TOUCH | Oct 21, 2014 | Substantially Equivalent |
| K133837 | VIORA V-TOTAL | Apr 9, 2014 | Substantially Equivalent |
| K090221 | REACTION SYSTEM | Jul 1, 2009 | Substantially Equivalent |
| K090399 | TRIOS SYSTEM | Jun 10, 2009 | Substantially Equivalent |