The following data is part of a premarket notification filed by Ellipse A/s with the FDA for Ellipse Nordlys/ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra.
| Device ID | K150907 |
| 510k Number | K150907 |
| Device Name: | Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra |
| Classification | Powered Laser Surgical Instrument |
| 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 | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-03 |
| Decision Date | 2015-07-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05713530000178 | K150907 | 000 |
| 05713530000390 | K150907 | 000 |
| 05713530000383 | K150907 | 000 |
| 05713530000376 | K150907 | 000 |
| 05713530000369 | K150907 | 000 |
| 05713530000352 | K150907 | 000 |
| 05713530000345 | K150907 | 000 |
| 05713530000338 | K150907 | 000 |
| 05713530000253 | K150907 | 000 |
| 05713530000079 | K150907 | 000 |
| 05713530000406 | K150907 | 000 |
| 05713530000499 | K150907 | 000 |
| 05713530000505 | K150907 | 000 |
| 00817495023403 | K150907 | 000 |
| 00817495023397 | K150907 | 000 |
| 00817495023380 | K150907 | 000 |
| 00817495023373 | K150907 | 000 |
| 00817495023366 | K150907 | 000 |
| 00817495023359 | K150907 | 000 |
| 00817495023342 | K150907 | 000 |
| 00817495023335 | K150907 | 000 |
| 00817495023328 | K150907 | 000 |
| 00817495023458 | K150907 | 000 |