DEKA LUXEA

Primary DI
08057017760429
Brand
DEKA LUXEA
Company
EL.EN. SPA
Model
M117B1
Catalog number
M117B1
Device 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 filterEmission activation is either by footswitch or fingerswitch.Electrical specifications are 115-240V~, 50-60Hz, 2300VA max.
Published
2020-01-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument
ONFPowered Light Based Non-Laser Surgical Instrument With Thermal Effect

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2
ONFPowered Light Based Non-Laser Surgical Instrument With Thermal EffectGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192539000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192539000Deka LuxeaEl.En Electronic Engineering Spa2019-12-16GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08057017760429PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08057017760429080570177604298057017760429

GMDN Terms#

Term, Definition table
TermDefinition
Multi-modality skin surface treatment systemA mains electricity (AC-powered) mobile (on wheels) assembly of devices that uses multiple therapeutic modalities [e.g., intense pulsed light (IPL), laser, and radio-frequency (RF) energy] in combination and/or in isolation for ablative and non-ablative treatment of the skin surface (e.g., removal of pigment/vascular lesions, scarring, acne, psoriasis, wrinkles, tattoos, hair, and skin resurfacing and rejuvenation). The system includes a lamp(s) and additional energy sources (typically a laser(s), and/or a RF generator); dedicated applicators (handpieces) intended to apply the different energies to the skin are also included.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius30 Degrees Celsius
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
436887608
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08057017760979EXIRAM126AC12026-02-16
08057017760962LUVOM117H12025-11-24
08057017760221DEKA Motus AXM112B1M112B12017-07-03
08057017760337DEKA Minisilk FTM081R1M081R12018-04-16
08057017760443Thermaeye PlusM081AN1M081AN12021-10-19
08057017760559ECHOLASER X4M095H1M095H12021-05-07
08057017760504ECHOLASER X4M095G1M095G12020-02-14
08057017760320ECHOLASER X4M095D1M095D12020-01-15
08057017760207SH1M077H3M077H32016-09-13
08057017760214DEKA HIRO 3.0M080K1M080K12016-09-13
08057017760498DEKA PHYSIQM120F1M120F12020-01-15
08057017760528DEKA SMARTPERIOM128A1M128A12022-04-05
08057017760856NIRVANAM117H12024-04-18
08057017760818ALLORA PROM126AC12024-02-14
08057017760726DEKA SmartXide UltraSpeed 2M110F12023-04-27
08057017760535DEKA PHYSIQM120F1M120F12020-12-11
08057017760719DEKA SCULPTM116H1M116H12023-04-27
08057017760733DEKA TRUISTM117B1M117B12023-04-27
08057017760665DEKA HELIXM133A1M133A12023-03-21
08057017760108DEKA SYNCHRO REPLA:Y EXCELLIUM 3.4M104K1M104K12016-09-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07898672790823Medical SanMEDICAL SAN INDUSTRIA DE EQUIPAMENTOS MEDICOS LTDAGEX2026-05-12
08056389701122EPI-C PLUSESPANSIONE MARKETING SPAGEX2026-04-30
07898786930030ZYE-ULTRA FDAVYDENCE MEDICALONF2026-02-18
07898786930047ONE FDAVYDENCE MEDICALONF2026-02-18
08034108513317DEKA LUXEA PLUSDEKA M.E.L.A. SRLGEX2025-12-16
08057622080004MTONE EVOM & T SRLONF2025-04-15
08057622080011MTONE EVOM & T SRLONF2025-04-15
08057622080028MT ONEM & T SRLONF2025-04-15
08057622080035MT ONEM & T SRLONF2025-04-15
08057622080042MT ONE DIAMONDM & T SRLONF2025-04-15
08052049500326Splendor XBIOS SRLGEX2025-01-16
08052049500333Splendor XBIOS SRLGEX2025-01-16
08052049500340Splendor XBIOS SRLGEX2025-01-16
08052049500357Splendor XBIOS SRLGEX2025-01-16
07898961835013ETHEREA-MXVYDENCE MEDICALONF2024-05-27
07898961835204ZYE YAGVYDENCE MEDICALONF2024-05-27
07898961835211ZYE ALXVYDENCE MEDICALONF2024-05-27
00851842007623LightScalpelLightscalpel, LLCGEX2023-06-26
08057017760733DEKA TRUISTEL.EN. SPAGEX2023-04-27
08059173390243Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-08-25
08033945937645Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-04-06
08033945939052Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-04-06
08056389700071E-LIGHT LINEESPANSIONE MARKETING SPAGEX2019-09-03
08056389700088E-LIGHT LINEESPANSIONE MARKETING SPAGEX2019-09-03
08057017760276DEKA SMARTXIDE²EL.EN. SPAGEX2019-03-15
08057017760283DEKA SMARTXIDE²EL.EN. SPAGEX2019-03-15
08057017760344DEKA MOTUS AYEL.EN. SPAGEX2019-03-15
08059173390021Youlaser CO2QUANTA SYSTEM SPAGEX2019-01-07