The following data is part of a premarket notification filed by Ellipse A/s with the FDA for Ellipse Juvia, Model 9eju7465.
| Device ID | K072023 |
| 510k Number | K072023 |
| Device Name: | ELLIPSE JUVIA, MODEL 9EJU7465 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | ELLIPSE A/S AGERN ALLE 11 Hoersholm, DK Dk-2070 |
| Contact | Ole Kofod |
| Correspondent | Ole Kofod ELLIPSE A/S AGERN ALLE 11 Hoersholm, DK Dk-2070 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-23 |
| Decision Date | 2007-09-12 |
| Summary: | summary |