Sound Surgical Technologies, LLC
United StatesFDA applicant, unverified
- Devices
- 6
- FDA recalls
- 2
At a glance
Market reach
- United States
- FDA recalls
What Sound Surgical Technologies, LLC makes
Sound Surgical Technologies, LLC manufactures ultrasound-based liposuction and tissue dissection systems, including the Origins Lipoharvesting System and the SoundVaser System. These devices use focused ultrasound energy to break down fat and separate tissue layers for minimally invasive procedures. The portfolio also includes the SoundVaser Dissection System and variations of the SoundVaser and PowerX liposuction systems, designed for cosmetic and reconstructive surgeries.
The company’s devices are classified as Class II and Unclassified (U) under FDA regulations, with most authorised through the 510(k) clearance process. Products are listed in the FDA’s 510(k) registry. The manufacturer is based in the United States.
Catalogue
Origins Lipoharvesting System Ref K120328
Regimes: 510(k) Registry: 510(k)Soundvaser System Ref K022051
Regimes: 510(k) Registry: 510(k)The Soundvaser Dissection System Ref K993868
Regimes: 510(k) Registry: 510(k)Sound Vaser System Ref K991791
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Sound Surgical Vaser 2.1 Lipo System Ref K110306
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 2 recalls initiated by Sound Surgical Technologies, LLC, the earliest on 2007-12-28 and the most recent on 2010-12-21. By recorded status: 2 terminated. The reasons filed fall into these groups: electrical or power. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2010
- 21 Dec 2010 Z-0939-2011 Unclassified (pre-2012) Terminated Surgical equipment, activated by a wireless foot switch, may remain powered on when switch is no longer depressed.
2007
- 28 Dec 2007 Z-0933-2008 Unclassified (pre-2012) Terminated Failure to shut-off: Surgical equipment, activated by a wireless foot switch with VASER system, may remain powered on when switch is no longer depressed.
Full distribution text
- 28 Dec 2007 Z-0933-2008 Unclassified (pre-2012) Terminated Failure to shut-off: Surgical equipment, activated by a wireless foot switch with VASER system, may remain powered on when switch is no longer depressed.
Frequently asked questions
How many devices does Sound Surgical Technologies, LLC have in the registry?
The registry currently lists 6 devices for Sound Surgical Technologies, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sound Surgical Technologies, LLC's devices?
Among its 6 most recently registered devices, Sound Surgical Technologies, LLC has devices listed in FDA 510(k) (6 devices).
What risk classes do Sound Surgical Technologies, LLC's devices fall under?
Among its 6 most recently registered devices, the classes recorded for Sound Surgical Technologies, LLC's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Sound Surgical Technologies, LLC?
FDA recall records list 2 recalls initiated by Sound Surgical Technologies, LLC, the most recent initiated on 21 Dec 2010. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Sound Surgical Technologies, LLC in the registry?
The most recently registered devices listed for Sound Surgical Technologies, LLC include ORIGINS LIPOHARVESTING SYSTEM, SOUNDVASER SYSTEM, THE SOUNDVASER DISSECTION SYSTEM and SOUND VASER SYSTEM.