Gigaalaser Company Ltd.
Wuhan Hubei, CN
GIGAALASER COMPANY LTD. appears in FDA device records in Wuhan Hubei, CN. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for Gigaalaser Company Ltd. between 2024 and 2025. The busiest year on record is 2025, with 3. The most recent is 2025, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2024 | 1 |
| 2025 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K242755 | Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B) | ILY | Substantially Equivalent | |
| K250018 | Medical Diode Laser Systems (THEIA808) | GEX | Substantially Equivalent | |
| 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 | |
| K230047 | Medical Diode Laser Systems | NVK | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3017181358 | 3017181358 | GIGAALASER COMPANY LTD. | B15-8F, Wuhan Hi-tech Medical Device Park, Gaoxin Road #818, East Lake New Technology Development Zone, Wuhan Hubei 430206 CN | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain