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

• 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: 2024-09-25The 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