DEKA LUXEA M117B1

GUDID 08057017760429

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.

EL.EN. SPA

Multi-modality skin surface treatment system

• Primary Device ID: 08057017760429
• NIH Device Record Key: 14f3ca08-935b-4919-bf2e-442e93d6caa5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DEKA LUXEA
• Version Model Number: M117B1
• Catalog Number: M117B1
• Company DUNS: 436887608
• Company Name: EL.EN. SPA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	08057017760429 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192539

FDA Product Code

• ONF: Powered Light Based Non-Laser Surgical Instrument With Thermal Effect

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-01-23
• Device Publish Date: 2020-01-15

Devices Manufactured by EL.EN. SPA

• 08057017760207 - SH1: 2025-04-18 The ASA LASER SH1 device is a medical device for carrying out therapy in the treatment of musculotendinous and joint pathologies
• 08057017760214 - DEKA HIRO 3.0: 2025-04-18 The ASA LASER HIRO 3.0 device is a medical device for carrying out therapy in the treatment of musculotendinous and joint pathol
• 08057017760856 - NIRVANA: 2024-04-26 The NIRVANA is a diode laser device indicated for hair removal and permanent hair reduction. The device is provided with two dif
• 08057017760818 - ALLORA PRO: 2024-02-22 The DEKA AGAIN PRO family is a medical laser family equipped with Nd:YAG 1064nm laser. The laser sources deliver the laser outpu
• 08057017760719 - DEKA SCULPT: 2023-05-05 The SCULPT is a medical device that used high frequency RF currents to produce a localized increase in temperature in subcutaneo
• 08057017760726 - DEKA SmartXide UltraSpeed 2: 2023-05-05 DEKA SmartXide UltraSpeed 2 is a 10,600 nm CO2 laser devices whit a maximum power of 40W. The laser source delivers the laser ou
• 08057017760733 - DEKA TRUIST: 2023-05-05 The DEKA TRUIST is a versatile medical platform that can be equipped with various types of laser and pulsed light handpieces. Th
• 08057017760665 - DEKA HELIX: 2023-03-29 The Helix system consists of: • Laser system console (containing the optical bench assembly and laser, the microcontroller con