Identity
- Trade Name
- GIGAA FDA UDI
- Generic Name
- General/multiple surgical diode laser system FDA UDI
- Model / Reference
- VELAII-15D FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974632230019 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- General/multiple surgical diode laser system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: General/multiple surgical diode laser system
Gigaa by Wuhan Gigaa Optronics Technology Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General/multiple surgical diode laser system.
- QuadroStar PRO — Asclepion Laser Technologies GmbH · Class II
- Doctor Diode Laser — LAMBDA SPA · Class II
- TxCell for IQ577, H/S 900BM/BQ & CSO9900 — Iridex Corporation · Class II
- Dornier MedTech — Dornier MedTech GmbH · Class II
- Assy Final HS SLA IQ532 Standard Mount — Iridex Corporation · Class II
- Visualase — MEDTRONIC NAVIGATION, INC. · Class I
- Epic S-Series Diode Laser System — Biolase, Inc. · Class II
- Ultrafast Diode Laser — DENTLIGHT INC. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Wuhan Gigaa Optronics Technology Co., Ltd.
Sources (1)
- FDA UDI 39e1bc9f-9b24-4a8f-822a-2ee8d8d9abed 32 fields · synced May 30, 2026