Ellex EYEONE
Ellex EYEONE is an ophthalmic ultrasound imaging system (FDA Class II) made by Ellex Medical Pty Ltd, cleared under FDA 510(k) K103608 on 27 Dec 2010 and listed in FDA GUDID since 9 Jun 2023 (UDI-DI 09342395000274), active as of 23 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 | Number09342395000274 | Date9 Jun 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK103608 | Date27 Dec 2010 | StatusActive |
Official records
- AccessGUDID record 09342395000274
- FDA 510(k) database K103608
Across registries
- FDA 510(k) K103608 decided 27 Dec 2010 Active
- FDA GUDID UDI-DI 09342395000274 listed 9 Jun 2023 Listed
Timeline
- Cleared FDA 510(k) K103608
- Listed FDA GUDID 09342395000274
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Ellex
- Generic name
- Ophthalmic ultrasound imaging system
- Model / reference
- EYEONE
- Primary DI / UDI-DI
- 09342395000274
- 510(k) Number
- FDA product code
- IYO, ITX
- GMDN term
- Ophthalmic ultrasound imaging system
- Device class
- Class II
- Regulation number
- 892.1560, 892.1570
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Ophthalmic ultrasound imaging system.