FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
UltraShape System
K Number: K162163
·
Decision Nov 17, 2016
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
29
Applicant Total
35
Review Days
107
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Basic Information
- Device Name
- UltraShape System
- K Number
- K162163
- 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
- Syneron Medical, Ltd.
- Date Received
- August 2, 2016
- Decision Date
- November 17, 2016
- 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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Other Clearances by Syneron Medical, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K170370 | ULTRASHAPE POWER SYSTEM | May 15, 2017 | Substantially Equivalent |
| K163415 | SlimShape System | Apr 20, 2017 | Substantially Equivalent |
| K161952 | UltraShape System | Nov 7, 2016 | Substantially Equivalent |
| K160896 | ULTRASHAPE POWER SYSTEM | Jul 8, 2016 | Substantially Equivalent |
| K151655 | CO2RE System | Sep 15, 2015 | Substantially Equivalent |
| K141507 | TWO SKIN TREATMENT SYSTEM | Dec 8, 2014 | Substantially Equivalent |
| K141708 | ULTRASHAPE SYSTEM | Oct 6, 2014 | Substantially Equivalent |
| K133238 | CONTOUR I V3.1 SYSTEM | Apr 10, 2014 | Substantially Equivalent |
| K120510 | TRANSCEND | Jul 19, 2013 | Substantially Equivalent |
| K121598 | ME HAIR2GO | Oct 12, 2012 | Substantially Equivalent |