AccessGUDID - DEVICE: PRISMA (08034108512464)

GUDID

Device Identifier (DI) Information

Brand Name: PRISMA
Version or Model: M135A1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: DEKA M.E.L.A. SRL

Primary DI Number: 08034108512464
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 629381096 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
45220	Multi-modality skin surface treatment system	An electrically-powered assembly of devices intended to use multiple therapeutic modalities [e.g., intense pulsed light (IPL), laser, radio-frequency (RF) energy, microcurrent electrotherapy, electronic muscle stimulation (EMS), microdermabrasion, hydradermabrasion, oxygen skin application] in combination and/or in isolation for ablative and non-ablative treatment of the skin surface (e.g., removal of pigment/vascular lesions, scarring, acne, psoriasis, wrinkles, tattoos, hair, and skin resurfacing and rejuvenation). The system includes energy/therapy sources (e.g., lasers, lamps, generator) and dedicated applicators (handpieces) intended to apply the different therapies to the skin.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ONF	Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
GEI	Electrosurgical, Cutting & Coagulation & Accessories

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K233473	000
K250281	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3412f2d4-2a4b-4fcd-91af-54f5245a362e
Public Version Date: March 04, 2025
Public Version Number: 2
DI Record Publish Date: September 17, 2024