# K022228: Family of Iris Medical Endoprobe Handpieces

- Pathway: 510(k) (Traditional)
- Applicant: Iridex Corp
- Decided: Oct 8, 2002 after 90 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K894841 (1989). 14 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020374: Oculight SL/SLX, Iridex Corp (2002) Summary page 1.
- K962592: Ophthalas 532 Solid State Photocoagulator, or Equivalent Laser Systems, Alcon Laboratories (1996) Summary page 1.
- K931784: HGM Illuminating Imaging Endocular Probe, Hgm, Inc. (1994) Summary page 1.
- K925663: HGM Aspirating Endoocular (TM) Probe, Hgm, Inc. (1993) Summary page 1.
- K921488: Aspirating Endo Ocular Probe W/Illumination, Surgical Technologies, Inc. (1992) Summary page 1.
- K946135: Infinitech Aspirating Laser Probe, Surgical Technologies, Inc. (1995) Summary page 1.

## Most influential descendants
- K133019: Fiberion Ophthalmic Endolaser Probe (2015), 0 descendants of its own

## Indications for use
The family of IRIS Medical EndoProbe handpieces is intended for use in performing ophthalmic laser treatments to deliver laser energy to the treatment area inside the eye, the aspiration function is indicated for use when unwanted fluid is present in the eye causing refraction or scattering of the laser beam from the intended treatment site, and the illumination function is indicated for use to illuminate the interior of the eye. The handpieces are offered in straight or angled styles, and with a universal SMA connector that allows the family of EndoProbe handpieces to be used with compatible laser systems, such as IRIS Medical and Lumenis. The handpieces are cleared for use for the particular indications of the laser system to which they are attached.

Source page: https://510kreport.com/device/K022228
Methodology: https://510kreport.com/methodology