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510(k) Data Aggregation
K Number
K121703Device Name
LIPOKIT WITH DISPOSABLE 50CC AFT SYRINGE
Manufacturer
MEDI-KHAN USA, INC
Date Cleared
2012-12-07
(182 days)
Product Code
MUU
Regulation Number
878.5040Why did this record match?
Applicant Name (Manufacturer) :
MEDI-KHAN USA, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Lipokit is used in the tumescent injection, aspiration, harvesting, filtering and transferring of autologous fat tissue.
The Lipokit is intended for use in the following surgical specialities when the aspiration of soft tissue is desired:
- Plastic and Reconstructive Surgery
- General Surgery
- Dermatological Surgery
- Obstetrician & Gynecological Surgery .
- Cosmetic Surgery
The Lipokit is indicated for use when harvesting of highly concentrated pure fatty tissues for aesthetic body and facial contouring is desired.
Device Description
The Lipokit with disposable 50cc AFT Syringe is composed of one centrifuge unit with a motor for suction and positive pressure: a 50cc AFT (autologous fat transfer) syringe with weight-mesh piston, a cannula and other ancillary parts. The vacuum and positive pressure are controlled using a foot pedal control switch.
The Lipokit is a sterile, single-use, manual device consisting of a cannula, and tissue collection container (the 50cc AFT Syringe) that relies on the centrifuge unit for its energy supply. The cannula is attached directly to the 50cc AFT Syringe which simplifies and reduces the steps needed in the collection, filtering and transfer of the autologous fat. In so doing, the harvested fat is less traumatized and risk of contamination is lowered because the fat never leaves the harvesting syringe until reinjection. The cannula is a hollow tube with an opening near the tip to communicate the centrifuge unit to the tissues and subsequently aspirate, harvest and filter subcutaneous fatty tissues from the patient into the collection container (the 50cc AFT Syringe).
The stainless steel cannula that contacts the patient is provided a various sizes ranging from 2.5 -- 4.0mm in diameter. The tip region of the cannula may have a single or multiple openings that range in size from 170mm to 260mm in length distributed uniformly or randomly though the end of the cannula.
The 50cc AFT Syringe is a polymeric 50cc volume luer-lock style, single-use syringe consisting of a polypropylene barrel with printed graduations and a weight-mesh piston composed of polycarbonate.
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K Number
K083455Device Name
LIPOKIT WITH DISPOSABLE 50CC AFT SYRINGE, MODEL ZLK-100
Manufacturer
MEDI-KHAN USA, INC
Date Cleared
2009-05-18
(178 days)
Product Code
MUU
Regulation Number
878.5040Why did this record match?
Applicant Name (Manufacturer) :
MEDI-KHAN USA, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Lipokit is used in the tumescent injection, aspiration, harvesting, filtering and transferring of autologous fat tissue.
The Lipokit is intended for use in the following surgical specialties when the aspiration of soft tissue is desired:
- Plastic and Reconstructive Surgery .
- General Surgery .
- Dermatological Surgery .
- o Obstetrician & Gynecological Surgery
- . Cosmetic Surgery
The Lipokit is indicated for use when harvesting of highly concentrated pure fatty tissues for aesthetic body and facial contouring is desired.
Device Description
The Lipokit with disposable 50cc AFT Syringe is composed of one centrifuge unit with a motor for suction and positive pressure; a 50cc AFT (autologous fat transfer) syringe with weight-mesh piston, a cannula and other ancillary parts. The vacuum and positive pressures are controlled using a foot pedal control switch.
The Lipokit is a sterile, single-use, manual device consisting of a cannula, and a tissue collection container (the 50cc AFT Syringe) that relies on the centrifying unit for its energy supply. The cannula is attached directly to the 50cc AFT Syringe which simplifies and reduces the steps needed in the collection, filtering and transfer of the autologous fat. In so doing, the harvested fat is less traumatized and risk of contamination is lowered because the fat never leaves the harvesting syringe until re-injection. The cannula is a hollow tube with an opening near the tip to communicate the centrifuge unit to the tissues and subsequently aspirate, harvest and filter subcutaneous fatty tissues from the patient into the collection container (the 50cc AFT Syringe).
The stainless steel cannula that contacts the patient is provided in various sizes ranging from 2.5 - 4.0 mm in diameter. The tip region of the cannula may have a single or multiple openings that range in size from 170mm to 260mm in length distributed uniformly or randomly throughout the end of the cannula.
The 50cc AFT Syringe is a polymeric 50cc volume luer-lock style, single-use syringe consisting of a polypropylene barrel with printed graduations and a weight-mesh piston composed of polycarbonate.
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