Gigaalaser Company Ltd.
Manufacturer and brand owner in Wuhan, Hubei, China. 5 device types, 3 products catalogued, 4 clearances.
Gigaalaser Company Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Laser, Dental, Soft Tissue, Heat Source For Bleaching Teeth and 3 other device types. 3 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2022.
Registration
| Registered name | GIGAALASER COMPANY LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3017181358 |
| FEI number | 3017181358 |
| DUNS | 618495205 |
| Establishment type | Contract manufacturer, Manufacturer |
Location
| City | Wuhan |
|---|---|
| Province | Hubei |
| Address | B15-8F, Wuhan Hi-Tech Medical device park, #818 Gaoxin Road, Wuhan 430206, China |
| Postal code | 430206 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Heat Source For Bleaching Teeth | Class 1 | Medical Diode Laser Systems | 2024 | 56 |
| Lamp, Infrared, Therapeutic Heating | Class 2 | VelasII Therapy Laser System, Medical Diode Laser Systems | 2024 | 235 |
| Laser, Dental, Soft Tissue | Class 2 | Medical Diode Laser Systems | 2024 | 5 |
| Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis | Class 2 | Medical Diode Laser Systems | 2025 | 5 |
| Powered Laser Surgical Instrument | Class 2 | Medical diode laser systems THEIA, Medical diode laser systems GBOX-6H, Medical diode laser systems GBOX-10D, 12D, 15D, Medical diode laser systems VELAS Pro-30B15D, Lipo Dua, Medical diode laser systems VELASII-15D and 2 more | 2022 | 92 |
Own-Brand Listings
Clearances
4 clearances name Gigaalaser Company Ltd. as applicant. 2 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K242755 | 2025-05-19 | ILY | Traditional | This company |
| K250018 | 2025-04-01 | GEX | Traditional | This company |
| K241791 | 2025-03-19 | GEX | Traditional | This company |
| K230047 | 2024-03-04 | NVK | Traditional | This company |
| K160549 | 2017-04-07 | GEX | Traditional | Wuhan Gigaa Optronics Technology Co., Ltd. |
| K142078 | 2014-10-30 | ILY | Traditional | Aspen Laser Systems, LLC |
From the Company
Published by the company on its own website, not by the FDA.
| Main products | Medical diode lasers, Surgical lasers, Beauty lasers, Veterinary lasers |
|---|---|
| Export markets | More than 30 countries |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.