ELLIPSE MULTIFLEX
Powered Laser Surgical Instrument
ELLIPSE A/S
The following data is part of a premarket notification filed by Ellipse A/s with the FDA for Ellipse Multiflex.
Pre-market Notification Details
| Device ID | K081408 |
| 510k Number | K081408 |
| Device Name: | ELLIPSE MULTIFLEX |
| 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 | 2008-05-19 |
| Decision Date | 2008-10-17 |
| Summary: | summary |
Trademark Results [ELLIPSE MULTIFLEX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ELLIPSE MULTIFLEX 79050447 3547146 Dead/Cancelled |
Ellipse A/S 2008-01-31 |
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