Ellipse Sirius
by Ellipse A/S
Ellipse Sirius (9SYS7773) is a Class II device made by Ellipse A/S, listed in FDA GUDID since 5 Aug 2019 (UDI-DI 05713530000444), registry data as of 22 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number05713530000444 | Date5 Aug 2019 | StatusListed |
Official records
- AccessGUDID record 05713530000444
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Ellipse
- Generic name
- Intense pulsed light skin surface treatment system
- Model / Ref / Catalog
- Sirius, 9SYS7773
- Primary DI / UDI-DI
- 05713530000444
- FDA product code
- GEX
- GMDN term
- Intense pulsed light skin surface treatment system
- Device class
- Class II
- Regulation number
- 878.4810
- GUDID distribution status
- In Commercial Distribution
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