# K954460: Ilt Surgical Laser

- Pathway: 510(k) (Traditional)
- Applicant: Ion Laser Technology
- Decided: Dec 18, 1995 after 84 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.
5 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K971743: Sharplan CO2 Surgical Laser System (1997), 4 descendants of its own
- K132661: Lightscalpel (2014), 3 descendants of its own
- K141658: Light Scalpel (2014), 2 descendants of its own
- K213669: Lightscalpel LS-4020 (2023), 0 descendants of its own
- K173827: LightScalpel (2018), 0 descendants of its own

Source page: https://510kreport.com/device/K954460
Methodology: https://510kreport.com/methodology