# Ellex 6335740

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

- Canonical page: <https://devicerts.com/devices/ellex-6335740>
- Manufacturer: [Ellex Medical Pty Ltd](https://devicerts.com/manufacturers/ellex-medical-pty-ltd) (Australia)
- Device class: Class II (US FDA)
- FDA product code: HQF
- GMDN: Ophthalmic solid-state laser system, photodisruption (16947)

## Registrations and authorizations

- **GUDID** · GUDID listing · United States · UDI-DI 09342395000625 · listed 2016-09-24 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA 510(k) · United States · K081565 · decision 2008-07-02 · decision SESE · status: Active · from GUDID

## Recalls

- Z-1971-2023 · Class II · ongoing · initiated 2023-03-16: When using a Laser-Indirect-Ophthalmoscope (LIO) as the delivery device, a scattered laser beam inside the laser cavity system may unintentionally exit through the Slit Lamp output port (SDS) and get emitted from the Objective Lens when the laser is fired.

## Identity

- Trade name: Ellex [FDA GUDID (AccessGUDID)]
- Generic name: Ophthalmic solid-state laser system, photodisruption [FDA GUDID (AccessGUDID)]
- Model / reference: 6335740 [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 09342395000625 [FDA GUDID (AccessGUDID)]
- 510(k) Number: K081565 [FDA GUDID (AccessGUDID)]
- FDA product code: HQF [FDA GUDID (AccessGUDID)]
- GMDN term: Ophthalmic solid-state laser system, photodisruption (16947) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 886.4390 [FDA GUDID (AccessGUDID)]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

- Serial number: Yes [FDA GUDID (AccessGUDID)]
- Manufacturing date: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [FDA GUDID (AccessGUDID)]
- Sterilise before use: No [FDA GUDID (AccessGUDID)]
- Single use: No [FDA GUDID (AccessGUDID)]
- Implantable: No [FDA GUDID (AccessGUDID)]
- Contains latex: No [FDA GUDID (AccessGUDID)]
- Prescription use: No [FDA GUDID (AccessGUDID)]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Convenience kit: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Lot / batch number: No [FDA GUDID (AccessGUDID)]
- Expiration date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: Ellex 6335740, Ellex Medical Pty Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/ellex-6335740 (data as of 2026-11-14).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [FDA recalls](https://open.fda.gov/apis/device/recall/)
- Registry records last synced: 2026-10-23
- Statuses computed as of: 2026-11-14
- JSON: <https://devicerts.com/devices/ellex-6335740.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/ellex-6335740
- 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.