# Medical Diode Laser Systems

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

- Canonical page: <https://devicerts.com/devices/medical-diode-laser-systems-gex>
- Manufacturer: [Wuhan Gigaa Optronics Technology Co., Ltd.](https://devicerts.com/manufacturers/wuhan-gigaa-optronics-technology-co-ltd) (China)
- Device class: Class IIb (EU MDD); Class II (US FDA)
- FDA product code: GEX
- EMDN: Z12011016 DIODE SURGICAL LASER

## Overview

*AI-generated summary, 2026-09-18. Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record.*

The Medical Diode Laser Systems are classified as Diode Lasers (Device Type: GEX) and are designed for surgical and cosmetic applications in general and plastic surgery. These systems emit coherent light at specific wavelengths to perform procedures such as tissue ablation, coagulation, and vaporisation, leveraging the precision of diode laser technology for controlled medical interventions.

These systems are supplied by Wuhan Gigaa Optronics Technology Co., Ltd., and are intended for use in clinical settings where sterile conditions are required. They are regulated under the FDA’s 510(k) pathway, with a clearance decision dated December 23, 2015, and comply with the Medical Device Directive (MDD). No specific sterility or single-use/reusable designation is stated in the data, though typical laser systems in surgery are often used in sterile environments.

## Registrations and authorizations

- **EUDAMED** · CE/MDD · European Union · Basic UDI-DI B-06974632230323 · registered 2026-05-22 · status: Active
- **510(k)** · FDA 510(k) · United States · K151890 · decision 2015-12-23 · decision SESE · status: Active

## Recalls

No recall on record.

## Identity

- Model / reference: VELASⅡ-60B [EUDAMED]; GA.02.006.EN [EUDAMED]; VELASⅡ-30B [EUDAMED]; GA.02.003.EN [EUDAMED]; VELASⅡ-60A [EUDAMED]; GA.02.005.EN [EUDAMED]

## Identifiers

- Primary DI / UDI-DI: 06974632230323 [EUDAMED]; 06974632230224 [EUDAMED]; 06974632230330 [EUDAMED]
- Basic UDI-DI: B-06974632230323 [EUDAMED]; B-06974632230224 [EUDAMED]; B-06974632230330 [EUDAMED]
- 510(k) Number: K151890 [FDA 510(k)]
- FDA product code: GEX [FDA 510(k)]
- EMDN code: Z12011016 [EUDAMED]

## Classification

- Device class: Class IIb [EUDAMED]; Class II [FDA 510(k)]
- Regulation: 21 CFR Part 878.4810 [FDA 510(k)]
- EU registration type: Legacy device (under a directive) [EUDAMED]
- EU market of registration: Germany [EUDAMED]
- Advisory committee: General, Plastic Surgery [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]

## Properties

- Reusable: Yes [EUDAMED]
- Supplied sterile: No [EUDAMED]
- Sterilise before use: No [EUDAMED]
- Implantable: No [EUDAMED]
- Contains latex: No [EUDAMED]
- Reprocessed single-use device: No [EUDAMED]
- Incorporates a substance derived from human blood or plasma: No [EUDAMED]
- Contains human tissues or cells: No [EUDAMED]
- Contains animal tissues or cells: No [EUDAMED]
- Administering medicine: No [EUDAMED]
- Measuring function: No [EUDAMED]
- Incorporates a medicinal substance: No [EUDAMED]

## Source and citation

- Cite as: Medical Diode Laser Systems, Wuhan Gigaa Optronics Technology Co., Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/medical-diode-laser-systems-gex (data as of 2026-11-14).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/), [EUDAMED](https://ec.europa.eu/tools/eudamed)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-14
- JSON: <https://devicerts.com/devices/medical-diode-laser-systems-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/medical-diode-laser-systems-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.