Deka Smartxide

FDA UDI

Class II (US FDA UDI)

by El.en. Spa

Identity

Trade Name: DEKA SMARTXIDE FDA UDI
Generic Name: Dermatological carbon dioxide laser system FDA UDI
Device Name: The Smartxide system consists in a carbon dioxide laser (CO2) with 30W of maximum power. The CO2 laser radiation is delivered to the treatment area through handpieces or a scanning unit (DOT scanner). FDA UDI
Model / Reference: M079R1 FDA UDI
Description: The Smartxide system consists in a carbon dioxide laser (CO2) with 30W of maximum power. The CO2 laser radiation is delivered to the treatment area through handpieces or a scanning unit (DOT scanner). FDA UDI

Identifiers

Catalog Number: M079R1 FDA UDI
Primary DI / UDI-DI: 08057017760078 FDA UDI
510(k) Number: K031440 FDA UDI
K072159 FDA UDI
FDA Product Code: GEX FDA UDI
GMDN Term: Dermatological 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Dermatological carbon dioxide laser system

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

Similar devices

Also classified as Dermatological carbon dioxide laser system.

MedArt Intenz — Medart A/S · Class II
5-Pk, external hygienic, CO2RE Intima — Candela Corporation · Class II
Fraxis Duo ARM — ILOODA.CO., LTD · Class II
Edge Arm — Jeisys Medical Inc. · Class II
Standard Hand-piece packing Assy, CO2RE — Candela Corporation · Class II
Secret PRO Scanner Handpiece — CLASSYS Inc. · Class II
ATL — Advanced Technology Laser Co., Ltd. · Class II
Secret PRO Main Unit — CLASSYS Inc. · Class II

Cleared under the same submission

K031440 also covers:

DEKA SMART US-20D — EL.EN. SPA

K072159 also covers:

DEKA SMART US-20D — EL.EN. SPA
DEKA SMARTXIDE 50 — EL.EN. SPA

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 3c552297-ae24-443d-84a6-2149003a2dc9 36 fields · synced Jun 9, 2026