Smart Kit Basic, Smart Kit Pro
FDA 510(k) K202443 · Bsl Co., Ltd.
510(k) numberK202443
Submission
- Device name
- Smart Kit Basic, Smart Kit Pro
- Applicant
- Bsl Co., Ltd.
Gimhae-Si, KR - Received
- August 26, 2020
- Decision date
- March 11, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MUU – System, Suction, Lipoplasty
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.5040
- Specialty
- General, Plastic Surgery
See Federal Register Notice at 86 FR 50887 Consolidation of Devices That Process Autologous Human Cells, Tissues, and Cellular and Tissue-Based Products at the Point of Care to Produce a Therapeutic Article (FRN) (FDA-2021-N-0881).
Other 510(k)s with product code MUU
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K210528 | IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat Body On…MUU · Traditional | Millennium Medical Technologies Inc (Dba Cellmyx) | 03/16/2022SE |
| K203800 | SyntrFuge SystemMUU · Traditional | Syntr Health Technologies, Inc. | 07/02/2021SE |
| K193539 | REVOLVE ENVI 600 Advanced Adipose SystemMUU · Traditional | Lifecell Corporation | 05/28/2020SE |
| K193363 | Dermapose RefreshMUU · Traditional | Puregraft, LLC | 04/14/2020SE |
| K182732 | JTL-250-01MUU · Traditional | Jointechlabs, Inc. | 11/18/2019SE |
| K191564 | Progenikine Concentrating System 25 mL SystemMUU · Traditional | Emcyte Corporation | 11/07/2019SE |
| K190386 | KTA Adipose Treatment KitMUU · Traditional | Stemics S.A.S | 10/10/2019SE |
| K190278 | AuraGen 123 Suction Lipoplasty System (A123)MUU · Traditional | Auragen Aesthetics, LLC | 05/03/2019SE |
| K172717 | Automatic Tissue Processing UnitMUU · Traditional | Bsl Co. | 05/25/2018SE |
| K172714 | LipiVageMUU · Traditional | Genesis Biosystems, Inc. | 12/08/2017SE |
More from Genesis Biosystems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K172717 | Automatic Tissue Processing UnitMUU · Traditional | 05/25/2018SE |
Questions and answers
When was Smart Kit Basic, Smart Kit Pro cleared by the FDA?
Smart Kit Basic, Smart Kit Pro (K202443) received a 510(k) decision of Substantially Equivalent on March 11, 2021, 197 days after the submission was received.
What is the product code of K202443?
The FDA product code is MUU – System, Suction, Lipoplasty, a Class II (moderate risk) device regulated under 21 CFR 878.5040.