PRISMA

GUDID 08034108512464

The DEKA PRISMA is a device provided with two pulsed light handpieces and a RF handpiece. The overall weight is approximately 62 kg and the sizes 47 x 56 x 106 cm (LxWxH) without external parts and reclined display and 47 x 56 x 202 cm (LxWxH) with handpiece holders at maximum extension Electrical requirements: 115V~, 50/60Hz, 2300VA. The operator interacts directly with the external portions of the system displayed in the following.

DEKA M.E.L.A. SRL

Multi-modality skin surface treatment system

• Primary Device ID: 08034108512464
• NIH Device Record Key: 3412f2d4-2a4b-4fcd-91af-54f5245a362e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRISMA
• Version Model Number: M135A1
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08034108512464 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233473

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: 2024-09-25
• Device Publish Date: 2024-09-17

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

• 08034108512464 - PRISMA: 2024-09-25The DEKA PRISMA is a device provided with two pulsed light handpieces and a RF handpiece. The overall weight is approximately 62 kg and the sizes 47 x 56 x 106 cm (LxWxH) without external parts and reclined display and 47 x 56 x 202 cm (LxWxH) with handpiece holders at maximum extension Electrical requirements: 115V~, 50/60Hz, 2300VA. The operator interacts directly with the external portions of the system displayed in the following.
• 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