FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
THE SOUNDVASER DISSECTION SYSTEM
K Number: K993868
·
Decision Dec 21, 1999
Classifications
1
FEI Numbers
115
Registration Numbers
116
Same Product Code
156
Applicant Total
6
Review Days
36
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Basic Information
- Device Name
- THE SOUNDVASER DISSECTION SYSTEM
- K Number
- K993868
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sound Surgical Technologies, LLC
- Date Received
- November 15, 1999
- Decision Date
- December 21, 1999
- Product Code
- LFL
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| LFL | Instrument, Ultrasonic Surgical | FDA unclassified | Unknown |
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Other Clearances by Sound Surgical Technologies, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K120328 | ORIGINS LIPOHARVESTING SYSTEM | Sep 17, 2012 | Substantially Equivalent |
| 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 |
| K991791 | SOUND VASER SYSTEM | Aug 12, 1999 | Substantially Equivalent |