SOUNDVASER SYSTEM
FDA 510(k) clearance K022051 · decided 2002-09-11
Clearance details
- K-number
- K022051
- Device name
- SOUNDVASER SYSTEM
- Applicant
- Sound Surgical Technologies, LLC
- Decision
- Substantially Equivalent
- Date received
- 2002-06-24
- Decision date
- 2002-09-11
- Days to decision
- 79 days
- Clearance type
- Traditional
- Product code
- QPB
- Device class
- 2
- Regulation number
- 878.5040
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Lafayette, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Linemaster Wireless Footswitch, VASER System, REF Vaser 2.0, Sound Surgical Technologies L recall (Z-0939-2011) | Sound Surgical Technologies, LLC | 2011-01-25 |
| Linemaster Wireless Footswitch Accessory, Model SP-9970214-005112010 and Model SP-9970214- recall (Z-0933-2008) | Sound Surgical Technologies, LLC | 2008-03-13 |