The following data is part of a premarket notification filed by Lutronic Corporation with the FDA for Infini Radiofrequency System.
| Device ID | K121481 |
| 510k Number | K121481 |
| Device Name: | INFINI RADIOFREQUENCY SYSTEM |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | LUTRONIC CORPORATION 6 NESHAMINY INTERPLEX, SUITE 207 Trevose, PA 19053 |
| Contact | Jhung Won Vojir |
| Correspondent | Jhung Won Vojir LUTRONIC CORPORATION 6 NESHAMINY INTERPLEX, SUITE 207 Trevose, PA 19053 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-18 |
| Decision Date | 2013-06-25 |
| Summary: | summary |