The following data is part of a premarket notification filed by Sejong Medical Co., Ltd. with the FDA for Lap-ix.
| Device ID | K200639 |
| 510k Number | K200639 |
| Device Name: | LAP-iX |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Sejong Medical Co., Ltd. 11, Sinchon 2-ro Paju-si, CN 10880 |
| Contact | Yoojung Choi |
| Correspondent | Priscilla Chung LK Consulting Group USA, Inc. 1150 Roosevelt STE 200 Irvine, CA 92620 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-10 |
| Decision Date | 2021-09-29 |