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The Lipogems System is a sterile medical device intended for the closed-loop processing of lipoaspirate tissue in medical procedures involving the harvesting, concentrating and transferring of autologous adipose tissue harvested with a legally marketed lipoplasty system. The device is intended for use in the following surgical specialties when the transfer of harvested adipose tissue is desired: orthopedic surgery, arthroscopic surgery, neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, general surgery, gynecological surgery, thoracic surgery, laparoscopic surgery, and plastic and reconstructive surgery when aesthetic body contouring is desired. Only legally marketed accessory items, such as syringes, should be used with the system. If harvested fat is to be transferred, the harvested fat is only to be used without any additional manipulation.

The Lipogems System is a pre-assembled device consisting of: - . An ABS processing unit (Lipogems Processing Unit) containing 5 stainless steel spheres and 2 stainless steel sieve filters; - An input washing line connected to the color-coded end cap of the processing unit; . - An access port for the loading of material to be processed with a Luer-lock connection and selfoccluding valve (color-coded end-cap); - . A drain line connected to the 'gray' end-cap of the processing unit; - An access port for the discharge of processed material with a Luer-lock connection and self-occluding valve (gray end-cap); - A bag for collecting waste material. The Lipogems System Processing Unit is supplied sterile, for single use only, and manufactured in two size variants with the same functional characteristics: - . LGD 240: Lipogems Processing Unit with 240 cc capacity and standard exit sieve; - . LGD 60: Lipogems Processing Unit with 60 cc capacity and standard exit sieve;

The Lipogems System is a sterile medical device intended for the closed-loop processing of lipoaspirate tissue in medical procedures involving the harvesting, concentrating and transferring of autologous adipose tissue harvested with a legally marketed lipoplasty system. The device is intended for use in the following surgical specialties when the transfer of harvested adipose tissue is desired: orthroscopic surgery, neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, gynecological surgery, thoracic surgery, laparoscopic surgery, and plastic and reconstructive surgery when aesthetic body contouring is desired. Only legally marketed accessory items, such as syringes, should be used with the system. If harvested fat is to be transferred, the harvested fat is only to be used without any additional manipulation.

The Lipogems System is a pre-assembled device consisting of: - An ABS processing unit (Lipogems Processing Unit) containing 5 stainless steel spheres and 2 stainless steel sieve filters; - An input washing line connected to the 'blue' end-cap the processing unit; - An access port for the loading of material to be processed with a Luer-lock connection and self-occluding valve (blue end-cap); - A drain line connected to the 'gray' end-cap of the processing unit; - An access port for the discharge of processed material with a Luer-lock connection and self-occluding valve (gray end-cap); - A bag for collecting waste material. The Lipogems System Processing Unit is supplied sterile, for single use only, and manufactured in two size variants with the same functional characteristics: - LGD 240: Lipogems Processing Unit with 240 cc capacity and standard exit sieve; - LGD 60: Lipogems Processing Unit with 60 cc capacity and standard exit sieve;

The Lipogems System is a sterile medical device intended for the closed-loop processing of lipoaspirate tissue for the purpose of transferring autologous adipose tissue for aesthetic body contouring (lipofilling) in applications including plastic and reconstructive surgery, neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, general surgery, orthopedic surgery, qynecological surgery, thoracic surgery, and laparoscopic surgery. Only legally marketed accessory items. such as syringes, should be used with the system. If harvested fat is to be reimplanted. the harvested fat is only to be used without any additional manipulation.

The Lipogems System is a pre-assembled device consisting of: - An ABS processing unit (Lipogems Processing Unit) containing 5 stainless steel spheres and . 2 stainless steel sieve filters; - . An input washing line connected to the 'blue' side the processing unit; - An access port for the loading of material to be processed with a Luer-lock connection and self-. occluding valve (blue side); - . A drain line connected to the gray side of the processing unit; - An access port for the discharge of processed material with a Luer-lock connection and selfoccluding valve (gray side); - . A bag for collecting waste material. The Lipogems System Processing Unit is manufactured in two size variants with the same functional characteristics: LGD 240: Lipogems Processing Unit with 240 cc capacity and standard exit sieve; LGD 60: Lipogems Processing Unit with 60 cc capacity and standard exit sieve; The intrinsic characteristics of the Lipogems fat treatment can be summarized as follows: - . Minimal handling of adipose tissue (only via mechanical action); - Maintenance of the vascular-stromal niches; ● - . Reduction of fat clusters to allow injection with fine needles, up to 27G; - . Removal of impurities, such as oil residues and blood. The result of processing with the Lipogens System is a homogeneous and micronized fraction of adjpose tissue, which allows a patient's subcutaneous fat to be processed for autologous reinjection within the operative procedure time. There is no direct interaction of the device with the patient, although the adipose tissue that is processed in the device comes from the patient and is returned to the same patient after processing. Interaction with other devices is necessary for operation of the Lipogems System, in particular, standard FDA cleared syringes are needed for the initial injection of adipose tissue into the processing unit, and for receiving the processed tissue upon completion of the processing steps. The steps of operation of the Lipogems System are: - The Lipogems processing unit receives a constant gravity feed of physiological saline through the 1. upper port. After first filling the processing unit with saline, adipose tissue is injected into the processing unit, where it undergoes a first reduction treatment and micronization of lipidic cluster as it passes through the input sieve. - 2. The processing unit is then shaken manually, causing the spheres contained within the processing unit to exert mechanical action on the tissue/saline emulsion and further reduce the lipidic clusters, preserving the vascular-stromal niches, while the continuous flow of saline eliminates oil and blood component residuals from the emulsion. The used saline is collected in the waste bag. Conducting the mechanical reduction while fully immersed in saline minimizes any traumatic action on the cells. - 3. After completion of the shaking/washing step, the solution appears clear (at the top of the processing unit) and the lipoaspirate is yellow (at the bottom). The saline flow is then stopped and the device is inverted. A second adipose cluster reduction takes place by pushing the floating adipose clusters through the second sieve, pushing fluid from below with a svringe. The reduced clusters pass out of the (now) top of the unit into a collecting syringe.