AccessGUDID - DEVICE: LUMIX ULTRA/PLUS (08057949171621)

GUDID

Device Identifier (DI) Information

Brand Name: LUMIX ULTRA/PLUS
Version or Model: LUMIX ULTRA 2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: LPLUS1601HP
Company Name: FISIOLINE SRL

Primary DI Number: 08057949171621
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 338384498 *Terms of Use

Device Description: LASER THERAPY UNIT LUMIX ULTRA/PLUS with 4 WAVELENGTH (650nm+810nm+910nm+1064nm)

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":	Yes
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?
36775	Skin laser scanner	An electromechanical device intended to enable a laser beam, produced by an appropriate laser, to be scanned uniformly over a broad field of skin, typically for the removal of skin lesions (e.g., birthmarks, pigmentations) and tattoos. A laser beam is typically so intensely focused that only a tiny area can be treated at a time; large areas of skin must be treated using a scanner which sweeps the beam back and forth over the total target area.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ILY	Lamp, Infrared, Therapeutic Heating

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K161198	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
Handling Environment Humidity: between 40 and 60 Percent (%) Relative Humidity
Handling Environment Temperature: between 10 and 40 Degrees Celsius
Storage Environment Humidity: between 40 and 60 Percent (%) Relative Humidity
Storage Environment Temperature: between 5 and 45 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Lumen/Inner Diameter: 20 Millimeter
Lumen/Inner Diameter: 1064 Nanometer
Lumen/Inner Diameter: 910 Nanometer
Lumen/Inner Diameter: 810 Nanometer
Lumen/Inner Diameter: 650 Nanometer

Device Record Status

Public Device Record Key: 405b5692-5855-48ff-a115-ee0dcba8eaad
Public Version Date: June 22, 2023
Public Version Number: 1
DI Record Publish Date: June 14, 2023