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Smartxide Tetra Pro

FDA UDIEUDAMED

Class II (US FDA UDI)

by Deka M.e.l.a. Srl

Identity

Trade Name
SMARTXIDE TETRA PRO FDA UDI
Generic Name
General/multiple surgical carbon dioxide laser system FDA UDI
Device Name
The SMARTXIDE TETRA PRO DEVICE consists of a 10,600nm carbon dioxide laser (CO2) laser with 40W of maximum power. The laser energy is delivered to the treatment area via an articulated arm and a delivery accessory connected to its distal end. The articulated arm is an optical assembly that delivers free beam laser radiation. It is made up of seven mirrors placed on rotating knuckles: the mechanical accuracy of the articulated arm allows the CO2 laser beam to travel inside it and along its axis regardless of the arm orientation. The device may be used in combination with scanning units in order to achieve greater predictability and reproducibility. The use with the scanning units is indicated for layer-by-layer char-free ablation, enhancing the safety of the treatment with more uniform, accurate and controllable impact such as ablative skin resurfacing. FDA UDI
Model / Reference
M118G1 FDA UDI
Description
The SMARTXIDE TETRA PRO DEVICE consists of a 10,600nm carbon dioxide laser (CO2) laser with 40W of maximum power. The laser energy is delivered to the treatment area via an articulated arm and a delivery accessory connected to its distal end. The articulated arm is an optical assembly that delivers free beam laser radiation. It is made up of seven mirrors placed on rotating knuckles: the mechanical accuracy of the articulated arm allows the CO2 laser beam to travel inside it and along its axis regardless of the arm orientation. The device may be used in combination with scanning units in order to achieve greater predictability and reproducibility. The use with the scanning units is indicated for layer-by-layer char-free ablation, enhancing the safety of the treatment with more uniform, accurate and controllable impact such as ablative skin resurfacing. FDA UDI

Identifiers

Primary DI / UDI-DI
08034108512808 FDA UDI
510(k) Number
K240497 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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: General/multiple surgical carbon dioxide laser system

Smartxide Tetra Pro by Deka M.e.l.a. Srl — Class II — MDR, MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

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

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

European Union Unknown

MDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Deka M.e.l.a. Srl

Sources (2)

  • FDA UDI 67f62495-16ca-4633-a613-590b193795d1 35 fields · synced Jun 18, 2026
  • EUDAMED 1 fields · synced Jun 2, 2026