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510(k) Data Aggregation
K Number
K112626Device Name
LIPSONIX(R) SYSTEM MODEL 2
Manufacturer
MEDICIS TECHNOLOGIES CORPORATION
Date Cleared
2011-10-20
(41 days)
Product Code
OHV
Regulation Number
878.4590Why did this record match?
Applicant Name (Manufacturer) :
MEDICIS TECHNOLOGIES CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LipoSonix system delivers high intensity focused ultrasound (HIFU) energy that can disrupt subcutaneous adipose tissue (SAT) to provide a non-invasive approach to achieve a desired aesthetic effect.
The LipoSonix system is specifically indicated for non-invasive waist circumference reduction
Device Description
The LipoSonix system is a cart-based medical device intended for non-invasive disruption of subcutaneous adipose tissue (SAT) by employing ultrasound energy. The system consists of a cart, a detachable handpiece and a user interface display in one unit.
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K Number
K100874Device Name
LIPOSONIX SYSTEM, MODEL 1 P00XXXX
Manufacturer
MEDICIS TECHNOLOGIES CORPORATION
Date Cleared
2011-08-19
(507 days)
Product Code
OHV
Regulation Number
878.4590Why did this record match?
Applicant Name (Manufacturer) :
MEDICIS TECHNOLOGIES CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LipoSonix system delivers high intensity focused ultrasound (HIFU) energy that can disrupt subcutaneous adipose tissue (SAT) to provide a non-invasive approach to achieve a desired aesthetic effect. The LipoSonix system is specifically indicated for non-invasive waist circumference reduction.
Device Description
The LipoSonix system is a cart-based system intended for non-invasive waist circumference reduction. The LipoSonix system uses ultrasound energy to disrupt subcutaneous adipose tissue (soft tissue). The system consists of a base, a treatment head (which contains the transducer) and a treatment arm in one unit.
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