# Diode Laser Therapy Systems

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

- Canonical page: <https://devicerts.com/devices/diode-laser-therapy-systems-alpha>
- Manufacturer: [BEIJING UNT Technology Co., Ltd.](https://devicerts.com/manufacturers/beijing-unt-technology-co-ltd) (China)
- Device class: Class IIb (EU MDR); Class II (US FDA)
- FDA product code: GEX
- EMDN: Z12011016 DIODE SURGICAL LASER
- GMDN: Dermatological diode laser system (58786)

## Registrations and authorizations

- **GUDID** · GUDID listing · United States · UDI-DI 06973663791049 · listed 2024-04-25 · status: Listed (GUDID: in commercial distribution)
- **EUDAMED** · CE/MDR · European Union · Basic UDI-DI 697366379104P9 · UDI-DI 06973663791049 · registered 2024-03-21 · status: Active
- **EUDAMED** · CE/MDR · European Union · CN24/00001171 · issued 2024-02-26 · expires 2029-02-26 · status: Active
- **510(k)** · FDA 510(k) · United States · K212978 · issued 2021-11-10 · status: Active

## EU certificates

- CN24/00001171 · Quality management system · MDR · notified body SGS Belgium NV · issued 2024-02-26 · expires 2029-02-26 · status: issued

## Recalls

No recall on record.

## Identity

- Generic name: Dermatological diode laser system [FDA GUDID (AccessGUDID)]
- Model / reference: Alpha [EUDAMED, FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 06973663791049 [EUDAMED, FDA GUDID (AccessGUDID)]
- Basic UDI-DI: 697366379104P9 [EUDAMED]
- Direct marketing DI: 06973663791049 [EUDAMED]
- 510(k) Number: K212978 [FDA GUDID (AccessGUDID)]
- FDA product code: GEX [FDA GUDID (AccessGUDID)]
- EMDN code: Z12011016 [EUDAMED]
- GMDN term: Dermatological diode laser system (58786) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class IIb [EUDAMED]; Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 878.4810 [FDA GUDID (AccessGUDID)]
- EU registration type: Standard device [EUDAMED]
- EU market of registration: Germany [EUDAMED]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Clinical & Handling

- MRI safety: MR Safe [FDA GUDID (AccessGUDID)]

## Properties

- Serial number: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Sterilise before use: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Single use: No [FDA GUDID (AccessGUDID)]
- Implantable: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reusable: No [EUDAMED]
- Contains latex: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reprocessed single-use device: No [EUDAMED]
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): 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]
- Contains endocrine-disrupting substances: No [EUDAMED]
- Administering medicine: No [EUDAMED]
- Measuring function: No [EUDAMED]
- Incorporates a medicinal substance: No [EUDAMED]
- 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)]
- Manufacturing date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: Diode Laser Therapy Systems, BEIJING UNT Technology Co., Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/diode-laser-therapy-systems-alpha (data as of 2026-11-14).
- Data sources: [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [FDA 510(k)](https://open.fda.gov/apis/device/510k/)
- Registry records last synced: 2026-10-23
- Statuses computed as of: 2026-11-14
- JSON: <https://devicerts.com/devices/diode-laser-therapy-systems-alpha.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/diode-laser-therapy-systems-alpha
- 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.