Data / Medical devices / China / Gigaalaser Company Ltd.
Gigaalaser Company Ltd.: FDA-registered device maker in Wuhan Hubei, China, 6 510(k) clearances
Gigaalaser Company Ltd. is registered with the FDA (registration 3017181358) in Wuhan Hubei, China. It lists 5 device types. The FDA files 6 510(k) clearances under its listings, the newest dated May 19, 2025. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3017181358
- Address
- B15-8F, Wuhan Hi-tech Medical Device Park, Gaoxin Road #818, East Lake New Technology Development Zone (Pilot Free Trade Zone Wuhan Area), Wuhan Hubei, China, 430206
- Owner or operator
- Gigaalaser company ltd. (10085437)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- June 17, 2022
- Registered through
- 2026
- Brand names listed
- Lipo Dua, Medical Diode Laser Systems, Medical diode laser systems, Medical diode laser systems GBOX-10D, 12D, 15D, Medical diode laser systems GBOX-6H, Medical diode laser systems THEIA, Medical diode laser systems VELAS Pro-30B15D, Medical diode laser systems VELASII-15D and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Heat Source For Bleaching Teeth | EEG | 1 | Manufacturer | accessdata.fda.gov |
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Manufacturer | accessdata.fda.gov |
| Laser, Dental, Soft Tissue | NVK | 2 | Manufacturer | accessdata.fda.gov |
| Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis | PDZ | 2 | Manufacturer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 19, 2025 | K242755 | Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B) | ILY | Substantially Equivalent | Gigaalaser Company , Ltd. | accessdata.fda.gov |
| April 1, 2025 | K250018 | Medical Diode Laser Systems (THEIA808) | GEX | Substantially Equivalent | Gigaalaser Company , Ltd. | accessdata.fda.gov |
| March 19, 2025 | K241791 | Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D, VELAS II-6H, VELAS II-15D) | GEX | Substantially Equivalent | Gigaalaser Company , Ltd. | accessdata.fda.gov |
| March 4, 2024 | K230047 | Medical Diode Laser Systems | NVK | Substantially Equivalent | Gigaalaser Company , Ltd. | accessdata.fda.gov |
| April 7, 2017 | K160549 | MEDICAL DIODE LASER SYSTEMS | GEX | Substantially Equivalent | Wuhan Gigaa Optronics Technology Co., Ltd. | accessdata.fda.gov |
| October 30, 2014 | K142078 | VELASII THERAPY LASER SYSTEM | ILY | Substantially Equivalent | Aspen Laser Systems, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Powered Laser Surgical Instrument
- All makers of Laser, Dental, Soft Tissue
- All makers of Heat Source For Bleaching Teeth
- All makers of Lamp, Infrared, Therapeutic Heating
- All makers of Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
Updated May 19, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.