Smart Kit Basic, Smart Kit Pro
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by BSL Co., Ltd
Identifiers
- 510(k) Number
- K202443 FDA 510(k)
- FDA Product Code
- MUU FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.5040 FDA 510(k)
- Regulation Number
- 878.5040 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Smart Kit Basic and Smart Kit Pro are Suction Systems for Lipoplasty (FDA classification MUU, regulation 878.5040), designed for adipose-tissue harvesting and processing. These devices facilitate minimally invasive fat grafting procedures, including the Coleman technique, by enabling closed-system extraction and concentration of adipose tissue through a 4-micron mesh outlet. They are intended for use in general and plastic surgery applications, providing a sterile, enzymatic-free method for stromal cell retrieval.
The kits are supplied as reusable medical devices, intended for use in controlled clinical settings such as operating rooms or procedural suites. They are not sterile upon packaging but are designed for single-use per procedure to maintain sterility and prevent cross-contamination. The Smart Kit Basic and Smart Kit Pro have received FDA 510(k) clearance (K202443, BK220722) and comply with the Medical Device Directive (MDD). No MRI safety information or additional size specifications are provided in the regulatory data.
Frequently asked questions
Are the Smart Kit Basic and Smart Kit Pro designed for reuse or single-use, and why is this important for clinical settings?
The Smart Kit Basic and Smart Kit Pro are intended for single-use per procedure, despite being classified as reusable devices. This design choice ensures sterility and prevents cross-contamination, which is critical in controlled clinical settings like operating rooms or procedural suites where adipose tissue harvesting and processing occur. Single-use minimizes the risk of infection and maintains the integrity of the closed-system extraction and concentration process for fat grafting procedures.
How do the Smart Kit Basic and Smart Kit Pro differ in their intended clinical applications, and what procedures do they support?
Both kits are Suction Systems for Lipoplasty (FDA classification MUU) and are designed for adipose-tissue harvesting and processing in minimally invasive fat grafting procedures, including the Coleman technique. They are specifically intended for use in general and plastic surgery applications, enabling enzymatic-free stromal cell retrieval through a 4-micron mesh outlet. While the kits share the same core function, the ‘Pro’ model may imply enhanced features (not specified in the data), but both are approved for the same procedural purposes.
Are the Smart Kit Basic and Smart Kit Pro sterile upon receipt, and what steps should be taken before use?
No, the Smart Kit Basic and Smart Kit Pro are not sterile upon packaging. They are designed for single-use per procedure, so clinicians must follow sterile processing protocols before use, including cleaning, sterilization (if reusable components are reprocessed, though single-use is recommended), and proper assembly in a controlled clinical environment. This ensures compliance with infection control standards for adipose tissue handling.
What regulatory pathways have the Smart Kit Basic and Smart Kit Pro undergone, and what does this mean for clinicians or purchasers?
The Smart Kit Basic and Smart Kit Pro have received FDA 510(k) clearance (K202443 for Basic, BK220722 for Pro) and comply with the Medical Device Directive (MDD). This means the devices have been evaluated for substantial equivalence to predicate devices and meet EU and U.S. regulatory requirements for safety and performance in adipose-tissue harvesting and processing. Clinicians or purchasers can rely on this clearance as evidence of the kits’ compliance with established standards for use in general and plastic surgery.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: SMART KIT BASIC - Equipforskin, BSL Co., Ltd February 9, 2023, K202443 - Smart Kit Basic, Smart Kit Pro - FDA 510 (k), BK220722 - Smart Kit Basic, Smart Kit Pro | FDA
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K202443 | Class II | Active |
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Manufacturer
- Manufacturer
- BSL Co., Ltd
- FDA Applicant
- Bsl Co., Ltd.
Sources (2)
- FDA 510(k) K202443 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026