FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ULTHERA SYSTEM
K Number: K134032
·
Decision Jun 20, 2014
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
29
Applicant Total
14
Review Days
171
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Basic Information
- Device Name
- ULTHERA SYSTEM
- K Number
- K134032
- 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
- Ulthera, Inc.
- Date Received
- December 31, 2013
- Decision Date
- June 20, 2014
- 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 |
Similar 510(k) Clearances
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Other Clearances by Ulthera, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K260618 | Ulthera® System | May 21, 2026 | Substantially Equivalent |
| K250418 | Ulthera System (UC-1 Control Unit PRIME Model 2.1) | May 13, 2025 | Substantially Equivalent |
| K243035 | Ulthera® System | Feb 24, 2025 | Substantially Equivalent |
| K233996 | Ulthera System (UC-1 Control Unit PRIME) | Feb 22, 2024 | Substantially Equivalent |
| K192185 | The Cellfina System | Oct 9, 2019 | Substantially Equivalent |
| K180623 | Ulthera System | May 4, 2018 | Substantially Equivalent |
| K161885 | The Cellfina System | Oct 5, 2016 | Substantially Equivalent |
| K153677 | The Cellfina System | Feb 25, 2016 | Substantially Equivalent |
| K150505 | Cellfina System | Jul 29, 2015 | Substantially Equivalent |
| K132028 | ULTHERA SYSTEM | Dec 11, 2013 | Substantially Equivalent |