# K243147: LGO-Surgical Laser Fibers

- Pathway: 510(k) (Traditional)
- Applicant: Light Guide Optics International, Ltd.
- Decided: Dec 21, 2024 after 82 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: 25 generations back to K943450 (1995). 405 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 407 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200234: Surgical laser fibers, Quanta System Spa (2020) Summary page 5.

## Most influential descendants
- K253007: Laser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); Laser Fiber (PT-OF-C-S); Laser Fiber (PT-OF-D-S); Laser Fiber (PT-OF-E-S); Laser Fiber (PT-OF-F-S) (2025), 0 descendants of its own

## Indications for use
LGO-Surgical Laser Fibers are intended to be used to deliver the laser radiation to the target tissue when used with any cleared/certified laser with operational wavelengths between 500 nm - 2200 nm equipped with SMA 905 standard or freestanding ferrule connector, as per the indications of the laser device used with.

Source page: https://510kreport.com/device/K243147
Methodology: https://510kreport.com/methodology