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510(k) Data Aggregation
K Number
K980771Device Name
LYSONIX SUCTION LIPOPLASTY SYSTEM
Manufacturer
LYSONIX, INC.
Date Cleared
1998-07-13
(136 days)
Product Code
QPB, MUU, OPB
Regulation Number
878.5040Why did this record match?
Applicant Name (Manufacturer) :
LYSONIX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LySonix Suction Lipoplasty System is intended for use in aesthetic body contouring.
Device Description
The LySonix Suction Lipoplasty System consists of an Aspiration Pump, Aspiration Cannulas, Sterile Tubing Set, Microbial Filter, Collection Canisters, and Canister Liners.
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K Number
K980763Device Name
LYSONIX LIPOPLASTY ACCESS PORT
Manufacturer
LYSONIX, INC.
Date Cleared
1998-05-28
(90 days)
Product Code
QPB, OPB
Regulation Number
878.5040Why did this record match?
Applicant Name (Manufacturer) :
LYSONIX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LySonix Lipoplasty Access Port is indicated for use as an access portal to the surgical site and to reduce trauma to the incision site caused by removal and re-entry of cannulas during lipoplasty procedures during aesthetic body contouring.
Device Description
The LySonix Lipoplasty Access Port is an instrument access portal designed for use during lipoplasty procedures for aesthetic body contouring. The device is inserted into the incision site and threaded into place. Once in place, the device threads retain the device in place and allow for the insertion of the lipoplasty cannula. The Lipoplasty Access Portal is designed to be substantially equivalent to Endoscopic Access Devices intended to provide access for surgical instruments and to protect the incision site from trauma during repeated insertion of the cannula during surgical procedures.
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K Number
K980454Device Name
LYSONIX ASPIRATION PUMP
Manufacturer
LYSONIX, INC.
Date Cleared
1998-03-18
(41 days)
Product Code
BTA
Regulation Number
878.4780Why did this record match?
Applicant Name (Manufacturer) :
LYSONIX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LySonix Aspiration Pump System is for the suction or aspiration of fluids and tissue during surgical procedures. The device is designed to operate with the LySonix 2000 Ultrasonic Surgical System or as a stand-alone aspiration system.
Device Description
The LySonix Aspiration Pump System is a stand-alone version of the aspiration component of the LySonix Ultrasonic Surgical System. The system is available as a tabletop unit or as part of an integrated Operative Workstation.
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K Number
K974233Device Name
LYSONIX IRRIGATION SYSTEM
Manufacturer
LYSONIX, INC.
Date Cleared
1998-02-03
(83 days)
Product Code
GBX
Regulation Number
878.4200Why did this record match?
Applicant Name (Manufacturer) :
LYSONIX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LySonix Irrigation System is intended for delivery of fluids during general surgical procedures. The device is designed to operate with the LySonix 2000 Ultrasonic Surgical System or as a stand-alone irrigation system. The LySonix Irrigation System is not indicated for the administration of parenteral fluids, infusion of drugs or for any life sustaining purposes.
Device Description
The LySonix Irrigation System is a stand-alone version of the irrigation component of the LySonix Ultrasonic Surgical System. The system is available as a tabletop unit or as part of an integrated Operative Workstation.
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K Number
K972958Device Name
LYSONIX TTD DELTA SCAVENGER SUCTION/ASPIRATION CANNULAS LYSONIX INFUSION DIAMOND CANNULAS
Manufacturer
LYSONIX, INC.
Date Cleared
1997-09-19
(39 days)
Product Code
GCJ, FGY
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
LYSONIX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LySonix Cannulas are instruments used for suction of fluids and tissue and for infusion of fluids during a variety of surgical procedures.
Device Description
The LySonix Suction/Aspiration and Infusion Cannulas are hollow stainless steel tubes, with a blunt, bullet, or spatula-shaped tip. The cannulas are provided with an attached handle. The Suction and Infusion Cannulas are each available in three cannula lengths and four diameters. The LySonix Suction/Aspiration and Infusion Cannulas will be provided non-sterile.
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