Deka Luxea

FDA UDI

Class II (US FDA UDI)

by El.en. Spa

Identity

Trade Name: DEKA LUXEA FDA UDI
Generic Name: Multi-modality skin surface treatment system FDA UDI
Device Name: The DEKA LUXEA is a versatile medical platform that can be equipped with various types of laser and pulsed light handpieces. Thanks to its universal connector it is possible to quickly insert and deactivate the various handpieces to cover a wide spectrum of application. The available handpieces are: - VIVID: 808±10 nm Laser - SPARKS: 1064nm Laser - PRISMA: 1064nm Q-Switched laser - VIRIDIS: Pulsed Light handpiece 15mmx13mm with integrated 500-1200 nm filter - LILAC: Pulsed Light handpiece 48mmx13mm with interchangeable filters - RUBER: Pulsed Light handpiece 48mmx17mm with integrated 550nm filter - LAZUR: Pulsed Light handpiece 48mmx13mm with integrated 420-950 nm filter Emission activation is either by footswitch or fingerswitch. Electrical specifications are 115-240V~, 50-60Hz, 2300VA max. FDA UDI
Model / Reference: M117B1 FDA UDI
Description: The DEKA LUXEA is a versatile medical platform that can be equipped with various types of laser and pulsed light handpieces. Thanks to its universal connector it is possible to quickly insert and deactivate the various handpieces to cover a wide spectrum of application. The available handpieces are: - VIVID: 808±10 nm Laser - SPARKS: 1064nm Laser - PRISMA: 1064nm Q-Switched laser - VIRIDIS: Pulsed Light handpiece 15mmx13mm with integrated 500-1200 nm filter - LILAC: Pulsed Light handpiece 48mmx13mm with interchangeable filters - RUBER: Pulsed Light handpiece 48mmx17mm with integrated 550nm filter - LAZUR: Pulsed Light handpiece 48mmx13mm with integrated 420-950 nm filter Emission activation is either by footswitch or fingerswitch. Electrical specifications are 115-240V~, 50-60Hz, 2300VA max. FDA UDI

Identifiers

Catalog Number: M117B1 FDA UDI
Primary DI / UDI-DI: 08057017760429 FDA UDI
510(k) Number: K192539 FDA UDI
FDA Product Code: ONF FDA UDI
GEX FDA UDI
GMDN Term: Multi-modality skin surface treatment 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

Category: Multi-modality skin surface treatment system

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

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2940 handpiece — Cynosure, LLC · Class II

Cleared under the same submission

K192539 also covers:

DEKA TRUIST — 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 14f3ca08-935b-4919-bf2e-442e93d6caa5 36 fields · synced Jun 9, 2026