# K100746: Fiber One

- Pathway: 510(k) (Traditional)
- Applicant: American Medical Systems
- Decided: Jun 11, 2010 after 87 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K062719 (2006). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062719: Greenlight HPS Series Surgical Laser System & Accessories, Laserscope (2006) Summary page 2.

## Most influential descendants
- K120870: Greenlight Moxy Fiber Optic (2012), 1 descendant of its own
- K202601: Single-use Sterile medical laser fiber (2020), 0 descendants of its own

## Recalls of this device
- Jul 14, 2010 · Not classified · Z-0834-2011: Product not intended for release was distributed, which may result in old components, not built to specifications, or undergo final testing

## Indications for use
Fiber One is a fiber optic delivery device intended for use with the GreenLight Laser System for its FDA cleared indications for use.

Source page: https://510kreport.com/device/K100746
Methodology: https://510kreport.com/methodology