SYMPHONY

GUDID 08034108512532

The DEKA AGAIN PRO family is a medical laser family equipped with Nd:YAG 1064nm laser. The laser sources deliver the laser output through a lens coupled user repleaceable optical fiber with a wider range of intercheangeable, quick release laser handpieces with electronic spot recognition.

DEKA M.E.L.A. SRL

Multi-modality skin surface treatment system

• Primary Device ID: 08034108512532
• NIH Device Record Key: 1bf58eed-7b4b-4b59-8f99-f306f27b5acb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SYMPHONY
• Version Model Number: M126AB1
• 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

• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08034108512532 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233090

FDA Product Code

• GEX: Powered Laser Surgical Instrument

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: 2023-11-08
• Device Publish Date: 2023-10-31

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

• 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
• 08034108512730 - PRISMA EMS MODULE: 2024-09-25 The PRISMA EMS MODULE device consists of a main unit that generates electrical pulses and delivers rectangular biphasic waveform
• 08034108512709 - DEKA SMARTXIDE PRO: 2024-04-17 The SmartXide PRO is a medical device indicated for incision, excision, ablation, vaporization and coagulation of body soft tiss
• 08034108512808 - SMARTXIDE TETRA PRO: 2024-04-16 The SMARTXIDE TETRA PRO DEVICE consists of a 10,600nm carbon dioxide laser (CO2) laser with 40W of maximum power. The laser ener
• 08034108512846 - Scar 3 PRO: 2024-04-12 The Scar 3 scanning unit is an optional scanner that can be connected to DEKA CO2 lasers. The Scar 3 is composed of the followin
• 08034108512655 - Elite iQ PRO: 2024-03-21 The Elite iQ PRO Laser System is indicated fot stable long-term or permanent hair reduction. Peramanent hair reduction is define
• 08034108512525 - AGAIN PRO: 2023-11-08 The DEKA AGAIN PRO family is a medical laser family equipped with Alexandrite 755nm laser and Nd:YAG 1064nm laser. The laser sou