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The intelliFat Disposable Adipose Tissue Harvesting and Transfer or BOD Kit is a sterile medical device intended for the closed-loop processing of lipoaspirate tissue in medical procedures involving the harvesting, 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, 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 intelliFat Disposable Adipose Tissue Harvesting and intelliFat BOD Kits are sterile single-use, disposable suction lipoplasty systems that are intended for closed-loop processing of lipoaspirate tissue in various medical procedures involving harvesting autologous adipose tissue. These kits contain stand-alone components that are assembled by the physician user. Primary components include: cannulae, filters, resizer, luer adapters, and syringe caps. The intelliFat Kits accommodate minimal handling of adipose tissue. These devices may be used in combination with FDA-cleared device such as syringes.

The SyntrFuge™ System is a sterile medical device used 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, urological surgery, general surgery, gynecological 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 SyntrFuge System is a sterile single use disposable medical device, comprised of three AdipoSets. Each AdipoSet is comprised of two AdipoChambers and one AdipoChip, two AdipoChambers attach to the AdipoChip by luer connectors. The SyntrFuge™ System concentrates lipoaspirate, following a syringe vacuum liposuction method. The SyntrFuge System is utilized in medical procedures where reinjection of adipose tissue into the same individual during the same surgical procedure is needed.

The Smart Kit is disposable and is indicated for autologous fat transfer is also technically called as autologous fat grafting or reinjection of concentrated adipose-tissue into the recipient body areas. The Smart kit can be used for concentration and transfer of homogenous adipose tissues with legally marketed lipoplasty system when the concentrated and homogenous fat tissue is re-injected into the recipient body areas of the same patient autologously. This device is intended for autologous fat transfer. The Smart Kit is intended for use in the following surgical specialties when the concentration of harvested adipose tissue is desired. Neurosurgery / Gastrointestinal Surgery / General surgery / Orthopedic Surgery / Gynecological Surgery / Thoracic Surgery / Laparoscopic Surgery / Arthroscopic Surgery / Plastic and reconstructive surgery

The fat harvested by liposuction, called as lipoaspirates, contains fat tissues, bloody impurities and tumescent solution. The harvested lipoaspirates are not appropriate for autologous fat transfer without removal of the bloody impurities and tumescent solution containing anesthetic agent, anti-coagulant agent, antibiotics and etc. In addition, the harvested fat tissues are not homogeneous and contain bigger fibrotic tissues. Smart kit is designed and developed for harvest of a variety of sizes of homogeneous adipose tissues in a closed sterile way for autologous fat transfer surgical technique. Using a separate cannula, Manual handheld suction unit, and plunger, aspirate the adipose tissue or fill the syringe with adipose tissue and centrifuge with the cap in front of the syringe. Centrifuged adipose tissue is divided into blood and fluid layer, adipose tissue layer, and free oil layer. Those are located at the bottom of the piston. After centrifugation, the plunger is pushed unlocked to the piston and free oil is drained to the outside of the syringe as the free oil moves to the top of the piston through the hole at the front of the piston. Open the cap in front of the syringe, lock the plunger completely and push it, the blood and fluid layers at the bottom of the adipose tissue will be drained and only the adipose tissue will remain inside the syringe. Depending on the syringe capacity, there are three types of piston: 10ml, 20ml, 60ml. The built-in filter adapter consists of a filter for separating the fiber and adipose tissue to facilitate movement through needles of lumpy adipose tissues and a body for receiving it. Connect the syringe containing the adipose tissue and the empty syringe to the connection parts at both ends of the built-in filter adapter and push the plunger of the syringe containing the adipose tissue to allow the adipose tissue to pass through the filter. Fiber and adipose tissues larger than the pore size is filtered, and adipose tissue smaller than the pore size of the filter is passed through to separate adipose tissue.

REVOLVE ENVI™ 600 System is used for aspiration, harvesting, filtering, and transferring of autologous adipose tissue for aesthetic body contouring. The system should be used with a legally marketed vacuum or aspirator as a source of suction. If harvested fat is to be re-implanted, the harvested fat is only to be used without any additional manipulation. REVOLVE ENVI™ 600 System is intended for use in the following surgical specialties when the aspiration of soft tissue is desired: plastic and reconstructive surgery, gastrointestinal and affiliated organ surgery, general surgery, orthopedic surgery, gynecological surgery, thoracic surgery, and laparoscopic surgery.

REVOLVE ENVI™ 600 Advanced Adipose System (REVOLVE ENVI 600 System) consists of a sterile, single-use canister and components intended to be used for harvesting, filtering and transferring of autologous adipose tissue. Such products have been classified by FDA as Class II devices under 21 CFR §878.5040. Suction Lipoplasty System. and assigned product code MUU. The subject device should be used with a legally marketed vacuum or aspirator apparatus as a source of suction. The adipose tissue is harvested from the patient using liposuction tubing and cannula that are supplied by the user or the institution. The harvested tissue is collected inside the device which contains an inner basket with 200 um mesh filter that can process up to 600 mL of collected tissue. A manual stirring assembly allows the user to mix the tissue and Lactated Ringer's during the washing step. The processed adipose tissue is removed from the device via an extraction port located on the bottom of the device using a syringe. The REVOLVE ENVI 600 System is comprised of the following components, intended to be used only as a system: - Canister (including mesh filter) - Syringe Adapter - Temperature Strip - Lactated Ringer's Tubing Set - Vacuum Tubing Set The device is offered in a single size, is packaged in a thermoformed tray and Tyvek® lidding and is sterilized via gamma irradiation. The device is a single-use device to be used in a healthcare facility.

The Dermapose Refresh is a sterile medical device intended for the closed-loop processing of lipoaspirate tissue in medical procedures involving the harvesting, concentrating 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, 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 Dermapose Refresh is a sterile, single use microsizing syringe system intended for the harvesting, concentrating, and transferring of autologous fat tissue back to the same patient when the transfer of harvested adipose tissue is desired. It consists of a 50 mL vacuum-lock syringe with a built-in, 800 um filter for screening the tissue particle size to allow for easier injection through small, 18-21G injection cannulas. For optimum performance, Dermapose™ Refresh should be used in conjunction with the Dermapose™ Refresh Stand, which is a reusable, autoclavable component designed to hold the syringe securely during use. The Dermapose™ Refresh is comprised of the following: 1. 50 mL polycarbonate harvesting and processing syringe unit preassembled with a 30 mL polycarbonate output syringe 2. Two 30 mL syringes 3. Three luer caps 4. Luer-to-luer adapter The Dermapose™ Refresh is also intended to be used with Lactated Ringer's solution, injection syringes (1 or 3 mL recommended), injection cannulas (18-21G recommended), and luer-lock harvest cannula (14G recommended) which are provided by the user. Dermapose™ Refresh should be used in conjunction with the 510(k)-exempt Dermapose TM Refresh Stand.

The JTL Tissue Processing Device is a sterile medical device intended for the 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 re-implanted, the harvested fat is only to be used without any additional manipulation.

The JTL-250-01 Tissue Processing Device is a centrifuge tube for processing lipoaspirate fat tissue that is intended for autologous homofunctional implant (lipofilling). The device is a pre-assembled, single-use centrifuge tube composed of a collection upper chamber, intermediate chamber, and a lower chamber. The diameter of the JTL Tissue Processing Device is 4.2 inches at the top ring and 3.6 inches in the main body. It stands 4 inches tall. The device weighs less than 1 pound. The components of the device are made of biocompatible materials. The device is sterilized by radiation and is intended for single use only. The JTL Tissue Processing Device is to be used in a healthcare facility. It is to be used and in contact with patient tissue for less than 24 hours and is made of materials that are biocompatible.

The Progenikine Concentrating System is used in medical procedures involving the harvesting of autologous adipose tissue. The Progenikine® Concentrating System is used for concentrating adipose tissue harvested with a legally marketed lipoplasty system. The Progenikine Concentrating System is intended for use in the following surgical specialties when the concentration of harvested adipose tissue is desired. Neurosurgery, Gastrointestinal Surgery, Urological Surgery, Plastic and Re-constructive Surgery, General Surgery, Orthopedic Surgery, Gynecological Surgery, Laparoscopic Surgery, Arthroscopic Surgery.

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The KTA Adipose Treatment Kit is intended for medical and surgical procedures involving autologous fat grafting that consists in: -harvesting, -centrifuging, and -reinjecting autologous adipose tissue, Within the same procedure. The KTA Adipose Treatment Kit range consists in a family of products which are designed to harvest, process with minimal manipulation and reinject small - KTAMICRO, KTAEASY, KTAMY - to large -KTAMACRO, KTAMACROMED, KTASPIN - volumes of autologous fat in the following specialties: Neurosurgery, Gastrointestinal Surgery, Urological Surgery, Plastic and Reconstructive Surgery, General Surgery, Orthopedic Surgery, Gynecological Surgery, Thoracic Surgery, Laparoscopic Surgery, Arthroscopic Surgery,

The KTA Adipose Treatment Kit consists of a sterile (EtO) single use disposable pack used for the aspiration, harvesting, centrifuging and reinjection of autologous adipose tissue during the same procedure. Each kit contains the necessary equipment such as syringes, cannulas, needles, containers, Luer Lock caps / connectors and a standard M8 single use nut for the centrifuge

The A123 is used for aspiration, harvesting, filtering and transferring of autologous adipose tissue for aesthetic body contouring. The system should be used with a legally marketed vacuum or aspirator apparatus as a source of suction. If harvested fat is to be re-implanted, the harvested fat is to be used without any additional manipulation. The A123 is intended for use in the following surgical specialties when aspiration of soft tissue is desired: plastic and reconstructive surgery, neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, general surgery, orthopedic surgery, gynecological surgery, thoracic surgery, and laparoscopic surgery.

The A123 is a suction lipoplasty system designed to be used in the operating room in conjunction with, and attached to, a user-provided liposuction cannula, a vacuum source, and a waste canister. The A123 allows the surgeon to conveniently and accurately harvest, wash, filter, concentrate, and transfer autologous adipose tissue for reinjection into the same patient for body contouring in cosmetic and reconstructive surgery applications during the same procedure in which autologous adipose tissue is collected. The system is a sterile, disposable unit for single patient use. The A123 consists of the following components: - Collection chamber - Collection mesh basket - Concentration chamber with fluid-absorbing pads - AuraClens™ powder packets - Outlet tube and drain valve with tube clamp - Mixing spatula The A123 is to be used together with FDA-cleared devices (such as a lipoplasty device [Product Code MUU, Requlation Number 21 CFR 878.50401, liposuction cannula, high vacuum tubing, waste container, syringes [e.g. 60 cc Toomev-tip svringes, Luer-Lock, Product Code KYZ1, and roomtemperature, sterile 0.9% normal saline solution, all provided by the user.

The Automatic Tissue Processing Unit is used in medical procedures involving the harvesting and transferring of autologous adipose tissue. The Automatic Tissue Processing Unit is used for concentrating adipose tissue harvested with a legally marketed lipoplasty system. The Automatic Tissue Processing Unit is intended for use in the following surgical specialties when the concentration of harvested adipose tissue is desired. - Neurosurgery Gastrointestinal Surgery Urological Surgery Plastic and Reconstructive Surgery General Surgery Orthopedic Surgery Gynecological Surgery Thoracic Surgery Laparoscopic Surgery Arthoscopic Surgery

The fat harvested by liposuction, called as lipoaspirates, contains fat tissues, bloody impurities and tumescent solution. The harvested lipoaspirates are not appropriate for autologous fat transfer without removal of the bloody impurities and tumescent solution containing anesthetic agent, anti-coagulant agent, antibiotics etc. In addition, the harvested fat tissues are not homogenous and contain uneven fibrotic tissues. So, for the purpose of in autologous fat transfer surgical technique. ACPU kit is designed and developed for harvest of the fine homologous adipose tissue in a sterile and closed way. ACPU needs to be centrifuged by using exclusive centrifuge (ACS Combo-A-Centrifuge/Product code: JQC) and the kits are single-use only.