TruFocus LIO Premiere, 810 LS
TruFocus LIO Premiere, 810 LS (87302) is an indirect binocular laser ophthalmoscope (FDA Class II; FDA product code HQF, Laser, Ophthalmic) made by Iridex Corporation, cleared under FDA 510(k) K170718 on 3 May 2017 and listed in FDA GUDID since 28 Mar 2018 (UDI-DI 00813125015688), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00813125015688 | Date28 Mar 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK170718 | Date3 May 2017 | StatusActive |
Official records
- AccessGUDID record 00813125015688
- FDA 510(k) database K170718
Across registries
- FDA 510(k) K170718 decided 3 May 2017 Active
- FDA GUDID UDI-DI 00813125015688 listed 28 Mar 2018 Listed
Recalls
-
- Terminated Z-1075-2018
It was discovered that the laser energy was not going where intended to put it, resulting in focal cataracts and iris burns.
Timeline
- Cleared FDA 510(k) K170718
- Recall initiated FDA recalls Z-1075-2018
- Listed FDA GUDID 00813125015688
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- TruFocus LIO Premiere
- Generic name
- Indirect binocular laser ophthalmoscope
- Model / Ref / Catalog
- TruFocus LIO Premiere, 810 LS, 87302
- Primary DI / UDI-DI
- 00813125015688
- 510(k) Number
- FDA product code
- HQF
- GMDN term
- Indirect binocular laser ophthalmoscope
- Device class
- Class II
- Regulation number
- 886.4390
- GUDID distribution status
- In Commercial Distribution
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