# Dental Diode Laser System

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

- Canonical page: <https://devicerts.com/devices/dental-diode-laser-system-gex>
- Manufacturer: [Lazon Medical Laser Co., Ltd.](https://devicerts.com/manufacturers/lazon-medical-laser-co-ltd) (China, FDA 510(k) applicant)
- Device class: Class II (US FDA)
- FDA product code: GEX
- GMDN: Dental diode laser system (60340)

## Registrations and authorizations

- **GUDID** · GUDID listing · United States · UDI-DI 06970750060040 · listed 2019-01-08 · status: Listed (GUDID: in commercial distribution)
- **510(k)** · FDA 510(k) · United States · K180967 · decision 2018-07-11 · decision SESE · status: Active

## Recalls

No recall on record.

## Identity

- Generic name: Dental diode laser system [FDA GUDID (AccessGUDID)]
- Model / Ref / Catalog: SOLASE-808 [FDA GUDID (AccessGUDID)]; 04 [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 06970750060040 [FDA GUDID (AccessGUDID)]
- 510(k) Number: K180967 [FDA 510(k), FDA GUDID (AccessGUDID)]
- FDA product code: GEX [FDA 510(k), FDA GUDID (AccessGUDID)]
- GMDN term: Dental diode laser system (60340) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class II [FDA 510(k), FDA GUDID (AccessGUDID)]
- Regulation: 21 CFR Part 878.4810 [FDA 510(k), FDA GUDID (AccessGUDID)]
- Advisory committee: General, Plastic Surgery [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Clinical & Handling

- Sterilisation method: Moist Heat or Steam Sterilization [FDA GUDID (AccessGUDID)]

## Properties

- Sterilise before use: Yes [FDA GUDID (AccessGUDID)]
- Prescription use: Yes [FDA GUDID (AccessGUDID)]
- Serial number: Yes [FDA GUDID (AccessGUDID)]
- Manufacturing date: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [FDA GUDID (AccessGUDID)]
- Single use: No [FDA GUDID (AccessGUDID)]
- Implantable: No [FDA GUDID (AccessGUDID)]
- Contains latex: 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: Dental Diode Laser System, Lazon Medical Laser Co., Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/dental-diode-laser-system-gex (data as of 2026-11-15).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/), [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/dental-diode-laser-system-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/dental-diode-laser-system-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.