The following data is part of a premarket notification filed by Ellipse A/s with the FDA for Ellipse Frax 1940 For Ellipse Nordlys And Ellipse Ydun.
| Device ID | K192951 |
| 510k Number | K192951 |
| Device Name: | Ellipse Frax 1940 For Ellipse Nordlys And Ellipse Ydun |
| 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 | 2019-10-21 |
| Decision Date | 2020-03-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817495023427 | K192951 | 000 |
| 05713530000482 | K192951 | 000 |
| 05713530000475 | K192951 | 000 |
| 00817495023489 | K192951 | 000 |