510(k) Report

FDA applicant

Iridex Corp

Mountain View, CA22 decisions1998–20231 recall

FDA records 22 decisions for Iridex Corp (Mountain View, CA) from 1998 to 2023: 22 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and HQF (Laser, Ophthalmic). Since 2016 its 510(k)s took a median of 37 days from receipt to decision, against 86 for FDA’s reviews in the same codes and years. Its devices cite 63 predicates, 20 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Iridex Corporation”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Iridex Corp’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2008: 12012: 12015: 12016: 12017: 12018: 12020: 12022: 22023: 1
2007high 2 (2022) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2018

2018: 1
2007high 1 (2018) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Iridex Corp by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Iridex Corp’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • GEXPowered Laser Surgical Instrument14decisions
  • HQFLaser, Ophthalmic8decisions

How long do its 510(k) reviews take?

Since 2016, its 7 510(k)s took a median of 37 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 86 days; 6 of its 7 were faster than that.

Whose devices does it build on?

Its devices cite 63 predicates; 20 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 46 times; 20 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K071687Famili of Iridex IQ Laser SystemsIridex Corp · 200813cite it
  • K020374Oculight SL/SLXIridex Corp · 20029cite it
  • K041930Varilite Laser SystemIridex Corporation · 20043cite it
  • K143154IRIDEX CycloG6 Laser System, MicroPulse P3 Drive, G-Probe (RFID)Iridex Corporation · 20153cite it
  • K031665Iris Medical Oculight GL/GLX Laser SystemsIridex Corp · 20033cite it
  • K020849Apex 800 Laser System, Model Apex 800Iridex Corp · 20023cite it

What has FDA decided for it lately?

  • K230228Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models)Iridex Corporation · 2023
  • K223132Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models)Iridex Corporation · 2022
  • K213592Iridex 810 LaserIridex Corporation · 2022
  • K202760Iridex 810 LaserIridex Corporation · 2020
  • K181662Iridex TruFocus LIO PremiereIridex Corporation · 2018
  • K170718Iridex TruFocus LIO PremiereIridex Corporation · 20171 recall
  • K162416IRIDEX Cyclo G6 Laser System, G-Probe IlluminateIridex Corporation · 2016
  • K143154IRIDEX CycloG6 Laser System, MicroPulse P3 Drive, G-Probe (RFID)Iridex Corporation · 2015

All 13 as Iridex Corp →All 9 as Iridex Corporation →

What has been recalled?

1 recall linked to its devices; the latest:

  • K170718Iridex TruFocus LIO Premiere" Laser Indirect Ophthalmoscope ( LIO ) The LIO is a…Feb 27, 2018Class II