The following data is part of a premarket notification filed by Bsl Co., Ltd with the FDA for Smart Kit Basic, Smart Kit Pro.
| Device ID | K202443 |
| 510k Number | K202443 |
| Device Name: | Smart Kit Basic, Smart Kit Pro |
| Classification | System, Suction, Lipoplasty |
| Applicant | BSL Co., Ltd 6-13, Chilsan-ro 237beon-gil Gimhae-si, KR |
| Contact | Jun Seok Lee |
| Correspondent | James W. Monroe Global RQC Med Device Solutions, LLC. 319 Shilling Dr. Somerset, NJ 08873 |
| Product Code | MUU |
| CFR Regulation Number | 878.5040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-26 |
| Decision Date | 2021-03-11 |