The following data is part of a premarket notification filed by Lutronic Corporation with the FDA for Lutronic Genius Radiofrequency System.
| Device ID | K180945 |
| 510k Number | K180945 |
| Device Name: | LUTRONIC GENIUS Radiofrequency System |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Lutronic Corporation Lutronic Center, 219, Sowon-ro Deogyang-gu, Goyang-si, KR 410220 |
| Contact | Jhung Won Vojir |
| Correspondent | James Childs Lutronic Corporation 19 Fortune Dr. Billerica, MA 01821 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-11 |
| Decision Date | 2018-12-10 |
| Summary: | summary |