# K200234: Surgical laser fibers

- Pathway: 510(k) (Special)
- Applicant: Quanta System Spa
- Decided: Feb 25, 2020 after 26 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: 24 generations back to K943450 (1995). 404 ancestors in all.
2 later devices descend 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)
- K170366: Laser Peripherals, LLC Family of Bare Laser Fibers, Laser Peripherals, LLC (2017) Summary page 4.
- K160513: Quanta System Surgical Laser fibers, Quanta System Spa (2016) Summary page 4.

## Most influential descendants
- K243147: LGO-Surgical Laser Fibers (2024), 1 descendant of its own
- 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
Surgical Laser fibers are intended to be used to deliver the laser radiation to the target tissue when used with any cleared/certified surgical laser with operational wavelengths between 500nm — 2200nm equipped with SMA 905 or SMA 906 or compatible connector, as per the indications of the laser device used with.

Source page: https://510kreport.com/device/K200234
Methodology: https://510kreport.com/methodology