AccessGUDID - DEVICE: DEKA PHYSIQ 360 (08057017760689)

GUDID

Device Identifier (DI) Information

Brand Name: DEKA PHYSIQ 360
Version or Model: M134A1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: M134A1
Company Name: DEKA M.E.L.A. SRL

Primary DI Number: 08057017760689
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 629381096 *Terms of Use

Device Description: The PHYSIQ 360 is a diode laser device. The device is provided with 4 applicators that deliver the laser energy to the patient (to subcutaneous tissue layers).

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?
60341	General/multiple surgical diode laser system	An electrically-powered device assembly in which input energy is used to excite a diode to emit a high-power therapeutic laser beam intended to incise, excise, ablate, vaporize and coagulate tissues for general surgery and/or multiple specialized surgical applications (non-dedicated) such as lipolysis, endovenous laser therapy (EVLT), percutaneous laser disc decompression (PLDD), benign prostatic hyperplasia (BPH) therapy, and ear/nose/throat (ENT) interventions. It includes a diode laser light source, flexible fibreoptic delivery cable, and controls/foot-switch.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PKT	Laser For Disruption Of Adipocyte Cells For Aesthetic Use

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K231971	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
Storage Environment Temperature: between 5 and 50 Degrees Celsius
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Temperature: between 10 and 35 Degrees Celsius
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 70 and 1060 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e68e73ca-87eb-4a56-b49b-991c4030521e
Public Version Date: May 22, 2025
Public Version Number: 2
DI Record Publish Date: October 11, 2023