MedX Rehab Portable Laser

Basic Information

• Brand Name: MedX Rehab Portable Laser
• Primary DI: 00628451918233
• Version / Model: 0915
• Company Name: MedX Health Corp
• Labeler DUNS: 202128257
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 11
• Public Version Date: 2022-12-08
• Public Version Status: Update
• Public Device Record Key: c34242f6-b36e-4719-9397-561c98d1a6e6

Device Description

The MedX Rehab Portable Laser cluster-stand alone, LCS 450, delivers high-quality Low Level Laser Therapy (LLLT). The battery powered, hand-held device is utilized to treat a variety of conditions such as swelling, bruising, pain management, inflammation and many other conditions. The device utilizes three near infrared laser diodes and one visible blue LED that deliver LLLT therapy. The MedX Portable Laser has a power output of 450 mW, and a wavelength of 808 nm and has been designed for licensed or certified healthcare professionals.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	890.5500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Direct Marking	00628451918226	GS1
Primary	00628451918233	GS1
Package	70628451918232	GS1	brown shipping carto	7	Not in Commercial Distribution	2019-02-27
Package	40628451918231	GS1	shipping carton box	4	Not in Commercial Distribution	2019-02-27
Package	50628451918238	GS1	shipping carton box	5	In Commercial Distribution
Package	30628451918234	GS1	shipping carton box	3	In Commercial Distribution
Package	20628451918237	GS1	shipping carton box	2	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K032231	000

Device Sizes

Type	Value	Unit	Text
Weight	113	Gram

Storage Conditions

• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 700 – 1060 millibar
• Type: Storage Environment Humidity
• Temperature Range: 20 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -4 – 149 Degrees Fahrenheit
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 700 – 1060 millibar
• Type: Handling Environment Humidity
• Temperature Range: 20 – 95 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 32 – 104 Degrees Fahrenheit