K202443 is an FDA 510(k) clearance for the Smart Kit Basic, Smart Kit Pro. This device is classified as a System, Suction, Lipoplasty (Class II - Special Controls, product code MUU).
Submitted by Bsl Co., Ltd. (Gimhae-Si, KR). The FDA issued a Cleared decision on March 11, 2021, 197 days after receiving the submission on August 26, 2020.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.5040. 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)..
| 510(k) Number | K202443 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 26, 2020 |
| Decision Date | March 11, 2021 |
| Days to Decision | 197 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | MUU - System, Suction, Lipoplasty |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.5040 |
| Definition | 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). |