The following data is part of a premarket notification filed by Ellipse A/s with the FDA for Ellipse I2pl+/ellipse Multiflex+.
| Device ID | K140670 |
| 510k Number | K140670 |
| Device Name: | ELLIPSE I2PL+/ELLIPSE MULTIFLEX+ |
| Classification | Powered Light Based Non-laser Surgical Instrument With Thermal Effect |
| Applicant | ELLIPSE A/S AGERN ALLE 11 Hoersholm, DK Dk-2970 |
| Contact | Ole Kofod |
| Correspondent | Ole Kofod ELLIPSE A/S AGERN ALLE 11 Hoersholm, DK Dk-2970 |
| Product Code | ONF |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-18 |
| Decision Date | 2014-09-25 |
| Summary: | summary |