Identity
- Trade Name
- DEKA SMARTXIDE TETRA FDA UDI
- Generic Name
- General/multiple surgical carbon dioxide laser system FDA UDI
- Device Name
- The Smartxide Tetra system consists in a carbon dioxide laser (CO2) with 50W of maximum power. The CO2 laser radiation is delivered to the treatment area through the handpieces or the scanning units. FDA UDI
- Model / Reference
- M118D1 FDA UDI
- Description
- The Smartxide Tetra system consists in a carbon dioxide laser (CO2) with 50W of maximum power. The CO2 laser radiation is delivered to the treatment area through the handpieces or the scanning units. FDA UDI
Identifiers
- Catalog Number
- M118D1 FDA UDI
- Primary DI / UDI-DI
- 08057017760306 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- General/multiple surgical carbon dioxide 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
Moist Heat or Steam Sterilization FDA UDI
Category: General/multiple surgical carbon dioxide laser system
Deka Smartxide Tetra by El.en. Spa — 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
- El.en. Spa
Sources (1)
- FDA UDI 3fd402f3-eb0d-413f-8266-1374e015485b 35 fields · synced Jun 9, 2026