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Deka Smartxide²

FDA UDI

Class II (US FDA UDI)

by El.en. Spa

Identity

Trade Name
DEKA SMARTXIDE² FDA UDI
Generic Name
General/multiple surgical diode/carbon dioxide laser system FDA UDI
Device Name
The SmartXide2 system consists in a 10,600nm carbon dioxide laser (CO2) laser with 80W of maximum power. It can be equipped with an optional diode laser source of 50W maximum power. The laser radiation is delivered to the treatment area through the handpieces or the scanning units. A wide range of handpieces can be provided with the SmartXide² system, having different spot sizes and high performances in specific application field. FDA UDI
Model / Reference
M103AB1 FDA UDI
Description
The SmartXide2 system consists in a 10,600nm carbon dioxide laser (CO2) laser with 80W of maximum power. It can be equipped with an optional diode laser source of 50W maximum power. The laser radiation is delivered to the treatment area through the handpieces or the scanning units. A wide range of handpieces can be provided with the SmartXide² system, having different spot sizes and high performances in specific application field. FDA UDI

Identifiers

Catalog Number
M103AB1 FDA UDI
Primary DI / UDI-DI
08057017760276 FDA UDI
510(k) Number
K113504 FDA UDI
FDA Product Code
GEX FDA UDI
GMDN Term
General/multiple surgical diode/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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: General/multiple surgical diode/carbon dioxide laser system

Deka Smartxide² by El.en. Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General/multiple surgical diode/carbon dioxide laser system.

Cleared under the same submission

K113504 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
El.en. Spa

Sources (1)

  • FDA UDI d8f2b7bd-c385-4242-9c2a-e010b1995366 36 fields · synced Jun 9, 2026