# K120870: Greenlight Moxy Fiber Optic

- Pathway: 510(k) (Special)
- Applicant: American Medical Systems
- Decided: Jun 15, 2012 after 85 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: 2 generations back to K062719 (2006). 2 ancestors in all.
1 later device descends 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)
- K100746: Fiber One, American Medical Systems (2010) Summary page 2.

## Most influential descendants
- K202601: Single-use Sterile medical laser fiber (2020), 0 descendants of its own

## Recalls of this device
- Mar 30, 2020 · Class II · Z-1798-2020: To reinforce existing instructions within the Directions for Use (DFU) and provide further guidance which will be added to the DFU that may reduce the likelihood of metal cap and fiber tip break tempe

## Indications for use
Model Number 00 10-2400 is a fiber optic delivery device intended for use with the GreenLightTM XPS Laser System for its FDA cleared indications for use.

Source page: https://510kreport.com/device/K120870
Methodology: https://510kreport.com/methodology