The following data is part of a premarket notification filed by Ellipse A/s with the FDA for Frax 1550 For Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra.
| Device ID | K161162 |
| 510k Number | K161162 |
| Device Name: | Frax 1550 For 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 | 2016-04-25 |
| Decision Date | 2016-09-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817495023410 | K161162 | 000 |
| 05713530000291 | K161162 | 000 |
| 05713530000277 | K161162 | 000 |