Ellex EYEONE
Ellex EYEONE is a Class II device 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- Withdrawn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.