Atlas FDA

THE SOUNDVASER DISSECTION SYSTEM

FDA 510(k) clearance K993868 · decided 1999-12-21

Clearance details

K-number
K993868
Device name
THE SOUNDVASER DISSECTION SYSTEM
Applicant
Sound Surgical Technologies, LLC
Decision
Substantially Equivalent
Date received
1999-11-15
Decision date
1999-12-21
Days to decision
36 days
Clearance type
Traditional
Product code
LFL
Device class
U
Medical specialty
Unknown
Advisory committee
Unknown
Location
Lafayette, CO, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Linemaster Wireless Footswitch, VASER System, REF Vaser 2.0, Sound Surgical Technologies L recall (Z-0939-2011)Sound Surgical Technologies, LLC2011-01-25
Linemaster Wireless Footswitch Accessory, Model SP-9970214-005112010 and Model SP-9970214- recall (Z-0933-2008)Sound Surgical Technologies, LLC2008-03-13