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510(k) Data Aggregation

    K Number
    K120328
    Device Name
    ORIGINS LIPOHARVESTING SYSTEM
    Manufacturer
    SOUND SURGICAL TECHNOLOGIES LLC.
    Date Cleared
    2012-09-17

    (228 days)

    Product Code
    MUU
    Regulation Number
    878.5040
    Why did this record match?
    Applicant Name (Manufacturer) :

    SOUND SURGICAL TECHNOLOGIES LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Origins LipoHarvesting System is used in the aspiration, harvesting, filtering and transferring of autologous tissue. If harvested fat is to be re-implanted, the harvested fat is only to be used without any additional manipulation. The Origins LipoHarvesting System is used in the aspiration, harvesting, filtering and transferring of adipose autologous tissue for aesthetic body contouring. If harvested fat is to be reimplanted, the harvested fat is only to be used without any additional manipulation.
    Device Description
    The Origins LipoHarvesting System consists of a reusable, closed loop tissue collection system comprised of a medical grade canister, a drain port and a lid intended to be used with a standard liposuction aspiration pump to collect fatty tissue for aesthetic body contouring. As the tissue is harvested from the patient, it enters the collection canister via a port in the canister lid. The physician removes unwanted waste materials from the collection system via the drain port at the base. This process leaves fatty tissue that can be transferred to syringes for autologous fat re-injection.
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    K Number
    K110306
    Device Name
    SOUND SURGICAL VASER 2.1 LIPO SYSTEM
    Manufacturer
    SOUND SURGICAL TECHNOLOGIES LLC.
    Date Cleared
    2011-06-23

    (141 days)

    Product Code
    QPB, MUU
    Regulation Number
    878.5040
    Why did this record match?
    Applicant Name (Manufacturer) :

    SOUND SURGICAL TECHNOLOGIES LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sound Surgical VASER 2.1 is intended for the fragmentation and emulsification of subcutaneous fatty tissues for aesthetic body contouring. The Sound Surgical VentX 2.1 is intended for the suction or aspiration of fluids and tissue during surgical procedures. The VentX 2.1 is designed to operate with the Sound Surgical VASER 2.1 or as a stand-alone system. The Sound Surgical VASER 2.1 Lipo System is intended for the fragmentation, emulsification and aspiration of subcutaneous fatty tissue for the purpose of aesthetic body contouring. The Sound Surgical VASER 2.1 Lipo System is also indicated for use in the following surgical specialties for the fragmentation, emulsification and aspiration of soft tissues: - Neurosurgery; - Gastrointestinal and affiliated organ surgery; - Urological surgery; - Plastic and reconstructive surgery; - General surgery - Gynecological surgery: - Thoracic surgery; and - Laparoscopic surgery.
    Device Description
    The Sound Surgical Technologies LLC (Sound) VASER 2.1 Lipo System (VASER 2.1) is an ultrasonic surgical system that fragments, emulsifies, and aspirates soft tissues. The Sound VASER 2.1 is comprised of two (2) primary components: (1) the Sound VASER 2.1 Ultrasonic Amplifier; and (2) the VentX 2.1 Infiltration and Aspiration Console. Both the Sound VASER 2.1 Ultrasonic Amplifier and the Sound VentX 2.1 Infiltration and Aspiration Console are designed to operate independently, and may be sold or used separately, or together, as a system. The VASER 2.1 Amplifier utilizes an ultrasonic surgical VASER Handpiece and Probe to fragment and emulsify the soft tissue. The VentX 2.1 Console utilizes sterile infiltration tubing, a handle and cannulae to infiltrate the tissue with fluids, and sterile suction tubing, a handle and cannulae to aspirate fluids and soft tissue.
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    K Number
    K110255
    Device Name
    SOUND SURGICAL TECHNOLOGIES LLC POWERX LIPO SYSTEM
    Manufacturer
    SOUND SURGICAL TECHNOLOGIES LLC.
    Date Cleared
    2011-04-04

    (66 days)

    Product Code
    QPB, MUU
    Regulation Number
    878.5040
    Why did this record match?
    Applicant Name (Manufacturer) :

    SOUND SURGICAL TECHNOLOGIES LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sound Surgical Technologies LLC PowerX Lipo System is intended for the removal of tissue or fluids from the body during general surgical procedures including suction lipoplasty for the purpose of aesthetic body contouring.
    Device Description
    The Sound Surgical Technologies LLC (Sound) PowerX Lipo System (PowerX) consists of three major components: (1) an electronic Controller with software, (2) an electronic Handpiece, and (3) a reusable, sterilizable Cannula. The Handpiece is connected to the Controller and to an independent aspiration source. The Controller sends electronic signals to the Handpiece and thereby controls the motion of the cannula that is fitted to the distal end of the Handpiece. The Sound PowerX is a prescription device, and is intended for use by trained medical personnel.
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    K Number
    K022051
    Device Name
    SOUNDVASER SYSTEM
    Manufacturer
    SOUND SURGICAL TECHNOLOGIES LLC.
    Date Cleared
    2002-09-11

    (79 days)

    Product Code
    QPB, LFL, MUU
    Regulation Number
    878.5040
    Why did this record match?
    Applicant Name (Manufacturer) :

    SOUND SURGICAL TECHNOLOGIES LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SoundVASER System is indicated for use in the following surgical specialties when the fragmentation, emulsification, and aspiration of soft tissue is desired: - Neurosurgery - - Gastrointestinal and Affiliated Organ Surgery - - Urological Surgery - - Plastic and Reconstructive Surgery - - General Surgery - - -Orthopedic Surgery - Gynecological Surgery - - Thoracic Surgery - - -Laparoscopic Surgery The SoundVASER System is indicated for use when the fragmentation, emulsification, and aspiration of subcutaneous fatty tissues for aesthetic body contouring is desired.
    Device Description
    The SoundVASER System is comprised of an ultrasonic generator (110/120 and 220/240 VAC, 50 & 60 Hz), an ultrasonic surgical handpiece with an ultrasonic surgical probe, and a suction/irrigation subsystem. The ultrasonic surgical handpiece converts electrical energy supplied by the ultrasonic generator into vibratory motion. The vibratory motion is applied to the ultrasonic surgical probe that is attached to the ultrasonic surgical handpiece. The vibratory motion at the tip of the ultrasonic surgical probe fragments and emulsifies contacted soft tissues. The suction/irrigation subsystem is used to remove the fragmented tissues.
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    K Number
    K993868
    Device Name
    THE SOUNDVASER DISSECTION SYSTEM
    Manufacturer
    SOUND SURGICAL TECHNOLOGIES LLC.
    Date Cleared
    1999-12-21

    (36 days)

    Product Code
    LFL
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    SOUND SURGICAL TECHNOLOGIES LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SoundVASER Dissection System (Dissection Tips and Handpiece for The SoundVaser System) is indicated for use in when cutting and coagulation of soft tissues is desired, including bleeding control with minimal thermal injury.
    Device Description
    The SoundVASER Dissection System is comprised of an ultrasonic surgical handpiece and associated dissection tips. The ultrasonic surgical handpiece converts electrical energy supplied by the SoundVASER ultrasonic generator into vibratory motion. The vibratory motion is applied to the dissection tip that is attached to the ultrasonic surgical handpiece. The vibratory motion at the tip cuts and coagulates contacted soft tissues.
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    K Number
    K991791
    Device Name
    SOUND VASER SYSTEM
    Manufacturer
    SOUND SURGICAL TECHNOLOGIES LLC.
    Date Cleared
    1999-08-12

    (79 days)

    Product Code
    LFL
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    SOUND SURGICAL TECHNOLOGIES LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SoundVASER System is indicated for use in the following surgical specialties when the fragmentation, emulsification, and aspiration of soft tissue is desired: Neurosurgery, Gastrointestinal and Affiliated Organ Surgery, Urological Surgery, Plastic and Reconstructive Surgery, General Surgery, Orthopedic Surgery, Gynecological Surgery, Thoracic Surgery, and Laparoscopic Surgery.
    Device Description
    The SoundVASER System is comprised of an ultrasonic generator (110/120 and 220/240 VAC, 50 & 60 Hz), an ultrasonic surgical handpiece with an ultrasonic surgical probe, and a suction/irrigation subsystem. The ultrasonic surgical handpiece converts electrical energy supplied by the ultrasonic generator into vibratory motion. The vibratory motion is applied to the ultrasonic surgical probe that is attached to the ultrasonic surgical handpiece. The vibratory motion at the tip of the ultrasonic surgical probe fragments and emulsifies contacted soft tissues. The suction/irrigation subsystem is used to remove the fragmented tissues. The suction and irrigation functions may be performed simultaneously or independently.
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