← Product Code [QKL](/productcode/QKL) · BK251199 # NLF system® kit 2 (EUROMI) (BK251199) _EUROMI S.A Belgium · QKL · Aug 14, 2025 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/device/BK251199 ## Device Facts - **Applicant:** EUROMI S.A Belgium - **Product Code:** [QKL](/productcode/QKL.md) - **Decision Date:** Aug 14, 2025 - **Decision:** SESE - **Regulation:** 21 CFR 878.5040 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Indications for Use The NLF System ® - Sterile fat cell collection and re-injection kits are used following lipoinfiltration during liposuction or lipofilling procedures. Liposuction is aimed at reducing the fat mass in one or more targeted areas of the human body for aesthetic or healing purposes. Lipofilling consists in transferring the fat from an area in the body into another in order to remodel or increase the volume of a body part. ## Device Story NLF System is a sterile, single-use disposable kit for collecting and re-injecting autologous fat. Used by healthcare professionals during liposculpture or lipofilling procedures. System components include a specific cannula, sterile canister, tubing, and elbows. Operates by connecting to an external aspiration device to harvest adipose tissue; fat is retained in an integrated micron filter to remove residue and purify the tissue. Purified fat is then withdrawn for autologous re-injection to remodel or increase volume in targeted body areas. Benefits include streamlined fat collection and purification within a closed system. ## Clinical Evidence No clinical data provided. Substantial equivalence is based on bench testing and technological comparison to the predicate device. ## Technological Characteristics Sterile, single-use disposable kit. Components: cannula, canister, tubing, elbows. Principle: vacuum-assisted aspiration and micron-filter purification. Sterilization: Ethylene oxide (SAL 10^-6). Volume capacity: up to 1000mL. Standalone device used with external aspiration source. ## Regulatory Identification A suction lipoplasty system is a device intended for aesthetic body contouring. The device consists of a powered suction pump (containing a microbial filter on the exhaust and a microbial in-line filter in the connecting tubing between the collection bottle and the safety trap), collection bottle, cannula, and connecting tube. The microbial filters, tubing, collection bottle, and cannula must be capable of being changed between patients. The powered suction pump has a motor with a minimum of 1/3 horsepower, a variable vacuum range from 0 to 29.9 inches of mercury, vacuum control valves to regulate the vacuum with accompanying vacuum gauges, a single or double rotary vane (with or without oil), a single or double diaphragm, a single or double piston, and a safety trap. ## Special Controls *Classification.* Class II (special controls). Consensus standards and labeling restrictions. ## Predicate Devices - The Red Head Collection Device ([BK220706](/device/BK220706.md)) - The Jordy Connection System ([BK220706](/device/BK220706.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} # FDA 510(k) Premarket Notification ## Euromi S.A _ NLF Kit system. ### 510(k) Summary. | **Device Name :** | NLF system® kit 2 | | --- | --- | | **510(k) Owner & Manufacturer :** | EUROMI S.A Zoning Industriel des Plenesses-11 rue des Nouvelles Technologies ANDRIMONT 4821 Belgium | | **510(k) Submitter and Contact :** | Perrine BENOIT Quality Engineer Perrine.benoit@cerecare.fr +32(0)87292222 | | **FDA Classification Name :** | 21 CFR Part 878 -General & Plastic Surgery 878.5040 - Suction lipoplasty system Classification product code: QKL (Class II) – Lipoaspirate Washing System for Aesthetic Body Contouring Secondary product code: QUB – Suction lipoplasty system for removal and transfer | | **Classification Panel :** | General & Plastic Surgery | | **Common Name** | Lipoplasty System | | **Predicate Device** | BK220706 The Red Head Collection Device The Jordy Connection System | | Device name | NLF System ® kit | The Red Head Miami Fat Supply | | --- | --- | --- | | **Device description** | The NLF System ® - Sterile fat cell collection and re-injection kit is a sterile disposable collection kit used following lipoinfiltration for liposuction coupled with a lipofilling. The kit is intended to recover the adipocytes of a patient in order to reinject them into another zone of their body. The NLF System ® - Sterile fat cell collection and re-injection kit is a sterile single-use kit destined to be used by a healthcare professional. The NLF System ® - Sterile fat cell collection and re-injection kit is a medical device intended to assist practitioners during liposculpture or lipofilling procedures. The NLF System ® makes it possible to retain the fat directly in a micron filter to remove residue and obtain purified fat. | The Red Head is a single use, closed loop tissue collection device comprised of a medical grade canister, vacuum port, collection port, tissue port and cap intended to be used with standard liposuction aspiration to collect fatty tissue for aesthetic body contouring. As the tissue is harvested from the patient it enters the canister through the collection port on the canister lid. The physician removes waste materials from the canister by closing the valve on the center of the lid. The fatty tissue remains that can be withdrawn through the tissue port on the bottom center of the canister for autologous fat re-injection. | {1} | **Picture of Product** | | | | --- | --- | --- | | **Intended Use:** | The NLF System ® - Sterile fat cell collection and re-injection kits are used following lipoinfiltration during liposuction or lipofilling procedures. Liposuction is aimed at reducing the fat mass in one or more targeted areas of the human body for aesthetic or healing purposes. Lipofilling consists in transferring the fat from an area in the body into another in order to remodel or increase the volume of a body part. | The Red Head is used in the aspiration, harvesting, filtering and extraction of autologous adipose tissue for aesthetic body contouring | | **Technology Comparison** | The NLF system kit employs the same technological characteristics as the predicate device. | The Red Head employs the same technological characteristics as the predicate device. | | **Suction Source** | Aspiration Device | Aspiration Device | | **Volume range** | Up to 1000mL | Up to 2500 mL | | **Shipped Sterile** | Yes | No, sterilized by user prior to use | | **Sterility Assurance Level** | 10^{-6} | 10^{-6} | | **Disposable or Reusable** | Single Use, Disposable | Single Use, Disposable | | **Resterilization Method** | Not Applicable | Not Applicable | #### Indications for Use : The NLF SYSTEM® kit is indicated for: - • Removing tissues and/or liquids from the body following an infiltration of tumescent solutions, during surgical procedures, including liposuction, intended for aesthetic body contouring - • Injecting autologous adipose tissues, “lipofilling”, for aesthetic body contouring purposes #### Device Description : The NLF System ® - Sterile fat cell collection and re-injection kit is a sterile disposable collection kit used following lipoinfiltration for liposuction coupled with a lipofilling. The kit is intended to recover the adipocytes of a patient in order to reinject them into another zone of their body. The NLF System ® - Sterile fat cell collection and re-injection kit is a sterile single-use kit destined to be used by a healthcare professional. The NLF System ® - Sterile fat cell collection and re-injection kit is a medical device intended to assist practitioners during liposculpture or lipofilling procedures. The NLF System ® makes it possible to retain the fat directly in a micron filter to remove residue and obtain purified fat. {2} # **Intended use :** The NLF System ® - Sterile fat cell collection and re-injection kits are used following lipoinfiltration during liposuction or lipofilling procedures. Liposuction is aimed at reducing the fat mass in one or more targeted areas of the human body for aesthetic or healing purposes. Lipofilling consists in transferring the fat from an area in the body into another in order to remodel or increase the volume of a body part. List of component : -Single use specific cannula -Sterile canister -Cannula tubing -Vacuum tubing -Elbows # **Predicate and Reference device comparison table :** | Device name | NLF System ® kit | The Red Head Miami Fat Supply | | --- | --- | --- | | **Device description** | The NLF System ® - Sterile fat cell collection and re-injection kit is a sterile disposable collection kit used following lipoinfiltration for liposuction coupled with a lipofilling. The kit is intended to recover the adipocytes of a patient in order to reinject them into another zone of their body. The NLF System ® - Sterile fat cell collection and re-injection kit is a sterile single-use kit destined to be used by a healthcare professional. The NLF System ® - Sterile fat cell collection and re-injection kit is a medical device intended to assist practitioners during liposculpture or lipofilling procedures. The NLF System ® makes it possible to retain the fat directly in a micron filter to remove residue and obtain purified fat. | The Red Head is a single use, closed loop tissue collection device comprised of a medical grade canister, vacuum port, collection port, tissue port and cap intended to be used with standard liposuction aspiration to collect fatty tissue for aesthetic body contouring. As the tissue is harvested from the patient it enters the canister through the collection port on the canister lid. The physician removes waste materials from the canister by closing the valve on the center of the lid. The fatty tissue remains that can be withdrawn through the tissue port on the bottom center of the canister for autologous fat re-injection. | | **Picture of Product** | | | | **Intended Use:** | The NLF System ® - Sterile fat cell collection and re-injection kits are used following lipoinfiltration during liposuction or lipofilling procedures. Liposuction is aimed at reducing the fat mass in one or more targeted areas of the human body for aesthetic or healing purposes. Lipofilling consists in transferring the | The Red Head is used in the aspiration, harvesting, filtering and extraction of autologous adipose tissue for aesthetic body contouring | {3} | | fat from an area in the body into another in order to remodel or increase the volume of a body part. | | | --- | --- | --- | | **Technology Comparison** | The NLF system kit employs the same technological characteristics as the predicate device. | The Red Head employs the same technological characteristics as the predicate device. | | **Suction Source** | Aspiration Device | Aspiration Device | | **Volume range** | Up to 1000mL | Up to 2500 mL | | **Shipped Sterile** | Yes | No, sterilized by user prior to use | | **Sterility Assurance Level** | 10^{-6} | 10^{-6} | | **Disposable or Reusable** | Single Use, Disposable | Single Use, Disposable | | **Resterilization Method** | Not Applicable | Not Applicable | #### **Substantial Equivalence Discussion :** The main difference between the subject device and predicate device is the sterility of the product. The NLF kit system is sterilized by the manufactured, with ethylene oxyde while the predicate product is not sterilized. The NLF kit system is sold with a sterile cannula, while the predicate is sold with a syringe. #### **Conclusion for the Substantial Equivalence of the Device :** Based on the performance and comparison date contained within this submission, the Red Head and Jordy Connection System deems that the NLF kit system is substantially equivalent to the identified predicate device. --- **Source:** [https://fda.innolitics.com/device/BK251199](https://fda.innolitics.com/device/BK251199) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com