# K982031: Oculight GL with the Dermatology Handpiece

- Pathway: 510(k) (Traditional)
- Applicant: Iridex Corp
- Decided: Sep 8, 1998 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 K933880 (1994). 7 ancestors in all.
22 later devices descend from it; 1 cites it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964074: Diolite 532, Iriderm Div. (1997) Summary page 2.
- K954905: CB Diode/532 Laser System, Continuum Biomedical, Inc. (1996) Summary page 2.
- K951034: Aura Laser System, Laserscope (1995) Summary page 2.
- K913569: Compac a, Elite a, Elite a Plus, Surgica a, Hgm Medical Laser Systems, Inc. (1991) Summary page 2.

## Most influential descendants
- K031665: Iris Medical Oculight GL/GLX Laser Systems (2003), 21 descendants of its own
- K062624: Next Generation Laser (2007), 18 descendants of its own
- K101285: Constellation Vision System (2010), 17 descendants of its own
- K121555: Centurion Vision System (2012), 6 descendants of its own
- K142877: EVA,anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser SMA connector) (2015), 5 descendants of its own

## Indications for use
The treatment of vascular and pigmented skin lesions.

Source page: https://510kreport.com/device/K982031
Methodology: https://510kreport.com/methodology