# K913430: Iris Oculight (R) SLX

- Pathway: 510(k) (Traditional)
- Applicant: Iriderm Div.
- Decided: Nov 15, 1991 after 106 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
No predicates in its family tree.
71 later devices descend from it; 3 cite it directly.
0 of 72 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K013760: DC-3300 Laser Diode Photocoagulator (2002), 70 descendants of its own
- K020374: Oculight SL/SLX (2002), 69 descendants of its own
- K043486: Pascal Photocoagulator, Product-Pascal-01 (2005), 29 descendants of its own
- K091666: Pascal Photocoagulator, Pascal-US (2009), 23 descendants of its own
- K092621: Pascal Streamline Photocoagulator (2009), 22 descendants of its own

Source page: https://510kreport.com/device/K913430
Methodology: https://510kreport.com/methodology