Ellipse A/S
FDA Regulatory Profile
Ellipse A/S appears in FDA public data with 2 recalls, 7 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1697-2016, Class II) was initiated on May 5, 2016. Its most recent 510(k) clearance was granted on March 26, 2020.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 7
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1697-2016 | Class II | Ellipse ND: YAG Laser applicator for Ellipse Multiflex Medical Laser Products. | May 5, 2016 |
| Z-1698-2016 | Class II | Ellipse ND: YAG Laser applicator for Ellipse Nordlys system Medical Laser Products. | May 5, 2016 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K192951 | Ellipse Frax 1940 for Ellipse Nordlys and Ellipse Ydun | March 26, 2020 |
| K180406 | Ellipse Ydun | March 15, 2018 |
| K161162 | Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, | September 16, 2016 |
| K150907 | Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys | July 7, 2015 |
| K140670 | ELLIPSE I2PL+/ELLIPSE MULTIFLEX+ | September 25, 2014 |
| K081408 | ELLIPSE MULTIFLEX | October 17, 2008 |
| K072023 | ELLIPSE JUVIA, MODEL 9EJU7465 | September 12, 2007 |