Identity
- Trade Name
- DEKA SMARTXIDE² FDA UDI
- Generic Name
- General/multiple surgical solid-state/carbon dioxide laser system FDA UDI
- Device Name
- The DEKA SmartXide² system is a medical laser system equipped with a 80W CO2 laser source and an (optional) 980nm or 940nm 50W diode laser source. The CO2 laser radiation has a wavelength of 10600nm and is delivered to the treatment area through an articulated arm and a delivery accessory connected to its distal end.The DEKA SmartXide² CO2 laser can be used with DEKA CO2 scanning units and the DEKA EasySpot Hybrid micromanipulator. The diode laser source can be provided in two alternative wavelengths: 940nm and 980nm. The diode laser radiation is delivered to the treatment area through optical fibers, which are guided to the target tissue with the aid of handpieces. FDA UDI
- Model / Reference
- M103J1 FDA UDI
- Description
- The DEKA SmartXide² system is a medical laser system equipped with a 80W CO2 laser source and an (optional) 980nm or 940nm 50W diode laser source. The CO2 laser radiation has a wavelength of 10600nm and is delivered to the treatment area through an articulated arm and a delivery accessory connected to its distal end.The DEKA SmartXide² CO2 laser can be used with DEKA CO2 scanning units and the DEKA EasySpot Hybrid micromanipulator. The diode laser source can be provided in two alternative wavelengths: 940nm and 980nm. The diode laser radiation is delivered to the treatment area through optical fibers, which are guided to the target tissue with the aid of handpieces. FDA UDI
Identifiers
- Catalog Number
- M103J1 FDA UDI
- Primary DI / UDI-DI
- 08057017760252 FDA UDI
- 510(k) Number
- K113504 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- General/multiple surgical solid-state/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 solid-state/carbon dioxide laser system
Deka Smartxide² by El.en. Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K113504 also covers:
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 73ab6147-a7aa-446a-b2d2-c28a111218fb 36 fields · synced Jun 9, 2026