The following data is part of a premarket notification filed by Ellipse A/s with the FDA for Ellipse Ydun.
| Device ID | K180406 |
| 510k Number | K180406 |
| Device Name: | Ellipse Ydun |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Ellipse A/S Agern Alle 11 Horsholm, DK Dk-2970 |
| Contact | Ole Kofod |
| Correspondent | Ole Kofod Ellipse A/S Agern Alle 11 Horsholm, DK Dk-2970 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-14 |
| Decision Date | 2018-03-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05713530000307 | K180406 | 000 |
| 05713530000246 | K180406 | 000 |
| 05713530000451 | K180406 | 000 |