FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ORIGINS LIPOHARVESTING SYSTEM
K Number: K120328
·
Decision Sep 17, 2012
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
39
Applicant Total
6
Review Days
228
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Basic Information
- Device Name
- ORIGINS LIPOHARVESTING SYSTEM
- K Number
- K120328
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.5040
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sound Surgical Technologies, LLC
- Date Received
- February 2, 2012
- Decision Date
- September 17, 2012
- Product Code
- MUU
- 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 |
|---|---|---|---|
| MUU | System, Suction, Lipoplasty | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Sound Surgical Technologies, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K110306 | SOUND SURGICAL VASER 2.1 LIPO SYSTEM | Jun 23, 2011 | Substantially Equivalent |
| K110255 | SOUND SURGICAL TECHNOLOGIES LLC POWERX LIPO SYSTEM | Apr 4, 2011 | Substantially Equivalent |
| K022051 | SOUNDVASER SYSTEM | Sep 11, 2002 | Substantially Equivalent |
| K993868 | THE SOUNDVASER DISSECTION SYSTEM | Dec 21, 1999 | Substantially Equivalent |
| K991791 | SOUND VASER SYSTEM | Aug 12, 1999 | Substantially Equivalent |