# Greenlight Moxy Fiber Optic

> Active: United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/greenlight-moxy-fiber-optic-gex>
- Manufacturer: [American Medical Systems](https://devicerts.com/manufacturers/american-medical-systems-inc) (United States, FDA 510(k) applicant)
- Name in the registry: GREENLIGHT MOXY FIBER OPTIC
- Device class: Class II (US FDA)
- FDA product code: GEX

## Registrations and authorizations

- **510(k)** · FDA 510(k) · United States · K120870 · decision 2012-06-15 · decision SESE · status: Active

## Recalls

- Z-1798-2020 · Class II · terminated · initiated 2020-03-30: 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 temperature related complaints.

## Identifiers

- 510(k) Number: K120870 [FDA 510(k)]
- FDA product code: GEX [FDA 510(k)]

## Classification

- Device class: Class II [FDA 510(k)]
- Regulation: 21 CFR Part 878.4810 [FDA 510(k)]
- Advisory committee: General, Plastic Surgery [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]

## Source and citation

- Cite as: Greenlight Moxy Fiber Optic, American Medical Systems. deviCERTS medical device catalogue. https://devicerts.com/devices/greenlight-moxy-fiber-optic-gex (data as of 2026-11-14).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/), [FDA recalls](https://open.fda.gov/apis/device/recall/)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-14
- JSON: <https://devicerts.com/devices/greenlight-moxy-fiber-optic-gex.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/greenlight-moxy-fiber-optic-gex
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.