LIGHTSonic B UBM US0000
LIGHTSonic B UBM US0000 is an ophthalmic ultrasound imaging system (FDA Class II) made by Light-Med(Usa), Inc., cleared under FDA 510(k) K170761 on 13 Apr 2018 and listed in FDA GUDID since 1 May 2018 (UDI-DI 00853386006285), 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 | Number00853386006285 | Date1 May 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK170761 | Date13 Apr 2018 | StatusActive |
Official records
- AccessGUDID record 00853386006285
- FDA 510(k) database K170761
Across registries
- FDA 510(k) K170761 decided 13 Apr 2018 Active
- FDA GUDID UDI-DI 00853386006285 listed 1 May 2018 Listed
Timeline
- Cleared FDA 510(k) K170761
- Listed FDA GUDID 00853386006285
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- LIGHTSonic B UBM
- Generic name
- Ophthalmic ultrasound imaging system
- Model / reference
- US0000
- Primary DI / UDI-DI
- 00853386006285
- 510(k) Number
- FDA product code
- ITX, IYO
- GMDN term
- Ophthalmic ultrasound imaging system
- Device class
- Class II
- Regulation number
- 892.1570, 892.1560
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Ophthalmic ultrasound imaging system.