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TruFocus LIO Premiere, 577

by Iridex Corporation

TruFocus LIO Premiere, 577 (87304) is a Class II device 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 00813125015657), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

510(k) K170718

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00813125015657 UDI-DI Date28 Mar 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK170718 Date3 May 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K170718 decided 3 May 2017 Active
  • FDA GUDID UDI-DI 00813125015657 listed 28 Mar 2018 Listed

Recalls

1 recall · FDA

    • Terminated Z-1075-2018 FDA Class II initiated 27 Feb 2018 on shared 510(k) K170718

    It was discovered that the laser energy was not going where intended to put it, resulting in focal cataracts and iris burns.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

3 dated events

  1. Cleared FDA 510(k) K170718
  2. Recall initiated FDA recalls Z-1075-2018
  3. Listed FDA GUDID 00813125015657

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
TruFocus LIO Premiere
Generic name
Indirect binocular laser ophthalmoscope
Model / Ref / Catalog
TruFocus LIO Premiere, 577, 87304
Primary DI / UDI-DI
00813125015657
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

Related devices

Category: Indirect binocular laser ophthalmoscope

Cleared under the same submission (K170718)

Similar devices

Other devices filed under FDA product code HQF (Laser, Ophthalmic).

Other devices from Iridex Corporation

See all devices from Iridex Corporation →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)