Identity
- Trade Name
- Hygea Diode Laser FDA UDI
- Generic Name
- Dental diode laser system FDA UDI
- Device Name
- Diode laser for soft tissue treatment procedures in the oral cavity FDA UDI
- Model / Reference
- 04778 FDA UDI
- Description
- Diode laser for soft tissue treatment procedures in the oral cavity FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00872320004842 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- Dental 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
Yes
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: Dental diode laser system
Hygea Diode Laser by Cao Group, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- Cao Group, Inc.
Sources (1)
- FDA UDI 6764a06f-3fa2-4ce3-bdb6-e693c1d85c8e 34 fields · synced May 31, 2026