Medical Diode Laser Systems
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Medical Diode Laser Systems EUDAMED
- Device Name
- Medical Diode Laser Systems EUDAMED
- Model / Reference
- VELASⅡ-60B EUDAMEDGA.02.006.EN EUDAMEDVELASⅡ-30B EUDAMEDGA.02.003.EN EUDAMEDVELASⅡ-60A EUDAMEDGA.02.005.EN EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974632230323 EUDAMED06974632230224 EUDAMED06974632230330 EUDAMED
- Basic UDI-DI
- B-06974632230323 EUDAMEDB-06974632230224 EUDAMEDB-06974632230330 EUDAMED
- 510(k) Number
- K151890 FDA 510(k)
- FDA Product Code
- GEX FDA 510(k)
- EMDN Code
- Z12011016 DIODE SURGICAL LASER EUDAMED
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4810 FDA 510(k)
- Regulation Number
- 878.4810 FDA 510(k)
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
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.
Frequently asked questions
What types of medical procedures can the Medical Diode Laser Systems be used for in clinical settings?
The Medical Diode Laser Systems are designed for surgical and cosmetic applications in general and plastic surgery. They emit coherent light to perform precise procedures like tissue ablation, coagulation, and vaporisation, making them suitable for controlled interventions where laser precision is beneficial.
Are these laser systems intended for single-use or can they be reused in a clinical environment?
The provided data does not explicitly state whether the Medical Diode Laser Systems are single-use or reusable. However, since they are intended for sterile clinical settings—where laser systems are typically reused with proper sterilization protocols—it is reasonable to assume they are designed for reuse with appropriate cleaning and sterilization procedures.
How is the Medical Diode Laser System regulated, and what does its clearance status mean?
The Medical Diode Laser Systems are regulated under the FDA’s 510(k) pathway and were granted clearance on December 23, 2015, under the product code GEX (Diode Lasers). The clearance decision indicates they are *substantially equivalent* to a legally marketed predicate device, meaning the FDA determined they have the same intended use and technological characteristics as an existing approved device.
What kind of maintenance or storage conditions should be followed for these laser systems?
While the data does not specify exact storage conditions, laser systems like these typically require protection from extreme temperatures, humidity, and direct sunlight. Since they are used in sterile environments, they should also be stored in a clean, dry area to maintain performance and hygiene standards. Always follow manufacturer guidelines for optimal care.
Who is the manufacturer, and how can I contact them for technical inquiries or support?
The Medical Diode Laser Systems are manufactured by Wuhan Gigaa Optronics Technology Co., Ltd., located at 5, 6/F, Unit A, B, Bldg. B8, Hi-Tech Medical Device Industrial Park, #818 Gaoxin Avenue, East Lake Development (430206, CN). For inquiries, you may contact the listed representative, Nie Xinxing, though direct contact details beyond the name are not provided in the data.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K151890 | Class II | Active |
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Manufacturer
- Manufacturer
- Wuhan Gigaa Optronics Technology Co., Ltd.
Sources (4)
- FDA 510(k) K151890 24 fields · synced Sep 18, 2026
- EUDAMED 2361e1d6-372b-4938-8284-5608856da7f4 61 fields · synced Jul 15, 2026
- EUDAMED 5eb53c20-9065-4f63-8a75-412a285dcaa1 61 fields · synced Jul 17, 2026
- EUDAMED b8d66642-d7cd-4102-9261-b4aecc2e966c 61 fields · synced Jul 21, 2026