# K202443: Smart Kit Basic, Smart Kit Pro

- Pathway: 510(k) (Traditional)
- Applicant: Bsl Co., Ltd.
- Decided: Mar 11, 2021 after 197 days
- Product code: MUU (System, Suction, Lipoplasty)
- Device class: 2
- Regulation: 21 CFR 878.5040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K910696 (1991). 32 ancestors in all.
No later device cites it as a predicate yet.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193363: Dermapose Refresh, Puregraft, LLC (2020) Summary page 4.

## Indications for use
The Smart Kit is disposable and is indicated for autologous fat transfer. The 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 / Urological Surgery / General surgery / Orthopedic Surgery / Gynecological Surgery /Thoracic Surgery / Laparoscopic Surgery / Arthroscopic Surgery / Plastic and reconstructive surgery

Source page: https://510kreport.com/device/K202443
Methodology: https://510kreport.com/methodology