AccessGUDID - DEVICE: Laserconn (06972558160021)

GUDID

Device Identifier (DI) Information

Brand Name: Laserconn
Version or Model: Theralas
Commercial Distribution Status: In Commercial Distribution
Catalog Number: Laser Therapy System
Company Name: Sanhe Laserconn Tech Co., Ltd.

Primary DI Number: 06972558160021
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 560439500 *Terms of Use

Device Description: Diode laser is intended to provide topical heating for the purpose of elevating tissue temperature for temporary relief of muscle and joint pain and stiffness, temporary increase local blood circulation and promoting relaxation of muscle

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?
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 [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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 Humidity: between 0 and 93 Percent (%) Relative Humidity
Storage Environment Temperature: between -40 and 55 Degrees Celsius
Handling Environment Humidity: between 0 and 70 Percent (%) Relative Humidity
Handling Environment Temperature: between 10 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 462.50 Micrometer
Width: 368.00 Micrometer
Height: 264.58 Micrometer

Device Record Status

Public Device Record Key: 2b96c95e-83ad-4cb8-ae58-cd64200c5d95
Public Version Date: December 08, 2022
Public Version Number: 2
DI Record Publish Date: June 28, 2021