DEKA LUXEA PLUS 117B1

GUDID 08034108513317

The DEKA LUXEA PLUS 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.

DEKA M.E.L.A. SRL

Multi-modality skin surface treatment system

• Primary Device ID: 08034108513317
• NIH Device Record Key: add9cd50-b8aa-4e54-b726-ba5589ed607d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DEKA LUXEA PLUS
• Version Model Number: M117B1
• Catalog Number: 117B1
• Company DUNS: 629381096
• Company Name: DEKA M.E.L.A. SRL
• 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

• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	08034108513317 [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: 2025-12-24
• Device Publish Date: 2025-12-16

Devices Manufactured by DEKA M.E.L.A. SRL

• 08034108513317 - DEKA LUXEA PLUS: 2025-12-24The DEKA LUXEA PLUS 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.
• 08034108513317 - DEKA LUXEA PLUS: 2025-12-24 The DEKA LUXEA PLUS is a versatile medical platform that can be equipped with various types of laser and pulsed light handpieces
• 08034108513270 - ONDA PRO: 2025-11-25 The ONDA PRO is a medical device that used high frequency RF currents to produce a localized increase in temperature in subcutan
• 08034108513263 - body ESTIQ: 2025-10-06 The body ESTIQ is a medical device that used high frequency RF currents to produce a localized increase in temperature in subcut
• 08034108513218 - OLO: 2025-09-04 Olo is a device which emits laser radiation with a wavelength of 532 nm, which is delivered to the tissue through a transfer fib
• 08034108512891 - MOTUS PRO: 2025-02-12 The MOTUS PRO is a medical laser equipped with Alexandrite 755nm laser and Nd:YAG 1064nm laser. The laser sources deliver the la
• 08034108512907 - MOTUS PRO AX: 2025-02-12 The MOTUS PRO AX is a medical laser equipped with Alexandrite 755nm laser only. The laser sources deliver the laser output throu
• 08034108512464 - PRISMA: 2024-09-25 The DEKA PRISMA is a device provided with two pulsed light handpieces and a RF handpiece. The overall weight is approximately 62
• 08034108512495 - DEKA LILY: 2024-09-25 The DEKA LILY device consists of a main unit that generates electrical pulses and delivers rectangular biphasic waveforms via el