AccessGUDID - DEVICE: Laser Sys*Stim 540 (00816864020425)

GUDID

Device Identifier (DI) Information

Brand Name: Laser Sys*Stim 540
Version or Model: ME 540
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ME 540
Company Name: METTLER ELECTRONICS CORP.

Primary DI Number: 00816864020425
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 008513913 *Terms of Use

Device Description: Therapeutic laser and light therapy

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?
60409	Musculoskeletal/physical therapy laser, professional	An electrically-powered diode laser intended to provide non-surgical laser therapy [e.g., infrared phototherapy, low-level laser therapy (LLLT)] for localized treatment of musculoskeletal conditions (e.g., muscle/joint pain, sports injury), improvement of local blood circulation in the treated areas to facilitate healing, or for non-needle acupuncture. It typically consists of a control unit which may be mounted on a mobile trolley, a foot-switch, and a connected applicator/beam guide designed for intra-orifice (e.g., intravaginal) or transcutaneous delivery of visible red/infrared laser light energy/heat. It is intended to be operated exclusively by a healthcare professional.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ILY	Lamp, infrared, therapeutic heating

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K043586	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
Special Storage Condition, Specify: No
Storage Environment Temperature: between 32 and 158 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Weight: 5.5 Pound

Device Record Status

Public Device Record Key: abed5930-bc0c-4cf8-8b21-a4062fc0d0d1
Public Version Date: December 08, 2022
Public Version Number: 6
DI Record Publish Date: September 15, 2016