Ellipse Nordlys
Ellipse Nordlys (9SYS7751) is a Class II device made by Ellipse A/S, cleared under FDA 510(k) K161162 on 16 Sep 2016 (1 earlier submission) and listed in FDA GUDID since 22 May 2018 (UDI-DI 05713530000178), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number05713530000178 | Date22 May 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK161162 | Date16 Sep 2016 | StatusActive |
Official records
- AccessGUDID record 05713530000178
- FDA 510(k) database K161162
- FDA 510(k) database K150907
Across registries
- FDA 510(k) K161162 decided 16 Sep 2016 Active
- FDA GUDID UDI-DI 05713530000178 listed 22 May 2018 Listed
Timeline
- Cleared FDA 510(k) K150907
- Cleared FDA 510(k) K161162
- Listed FDA GUDID 05713530000178
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Ellipse
- Generic name
- Multi-modality skin surface treatment system
- Model / Ref / Catalog
- Nordlys, 9SYS7751
- Primary DI / UDI-DI
- 05713530000178
- FDA product code
- GEX
- GMDN term
- Multi-modality skin surface treatment system
- Device class
- Class II
- Regulation number
- 878.4810
- GUDID distribution status
- In Commercial Distribution
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