FDA.reportPublic FDA data

MedX Rehab Portable Laser

Primary DI
00628451918226
Brand
MedX Rehab Portable Laser
Company
MedX Health Corp
Model
0915
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.
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
ILYLamp, Infrared, Therapeutic Heating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILYLamp, Infrared, Therapeutic HeatingPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K032231000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K032231000MEDX1100 CONSOLE & MEDX 100T AND DUOLIGHT LASER ACCESSORIES, MEDX 100 PORTABLE LASERMedx Electronics, Inc.2003-10-03ILY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00628451918226Direct MarkingGS10
20628451918237PackageGS12In Commercial Distribution
30628451918234PackageGS13In Commercial Distribution
40628451918231PackageGS14Not in Commercial Distribution
50628451918238PackageGS15In Commercial Distribution
70628451918232PackageGS17Not in Commercial Distribution
00628451918233PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628451918226006284519182266284519182260628451918226
2062845191823720628451918237
3062845191823430628451918234
4062845191823140628451918231
5062845191823850628451918238
7062845191823270628451918232
00628451918233006284519182336284519182330628451918233

GMDN Terms#

Term, Definition table
TermDefinition
Musculoskeletal/physical therapy laser, professionalAn 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), improving 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 internal (e.g., intravaginal) or transcutaneous delivery of visible red/infrared laser light energy/heat. It is intended to be operated by a healthcare professional exclusively in a clinical setting.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight113Gram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure700 millibar1060 millibar
Handling Environment Humidity20 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature32 Degrees Fahrenheit104 Degrees Fahrenheit
Storage Environment Atmospheric Pressure700 millibar1060 millibar
Storage Environment Humidity20 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-4 Degrees Fahrenheit149 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1 905 670 4428tobillo@medxhealth.com

Regulatory Flags#

DUNS number
202128257
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00628451918318MedX Oralase Tethered Laser2002018-10-17
00628451918288MedX Rehab Console1100N2018-10-17
00628451918127MedX Rehab Console System31102016-09-24
00628451918141MedX Rehab Console System31142016-09-24
00628451918158MedX Rehab Console System31162016-09-24
00628451918202MedX Oralase Portable Laser09102016-09-24
00628451918219MedX Acupuncture Portable Laser 09122016-09-24
00628451918233MedX Rehab Portable Laser09152016-09-24
00628451918257MedX Oralase Console System31202017-12-22
00628451918264MedX Oralase System31222017-12-27
00628451918325MedX Home Console20302018-10-17
00628451918349MedX Oralase Portable LaserLPS2002018-10-18
00628451918394MedX Rehab Portable Laser04552018-10-31
00628451918189MedX Home Unit - Light Therapy system20312016-09-24
00628451918295MedX SLD Light Cluster10012016-09-24
00628451918301MedX Rehab Tethered Laser4502016-09-24
00628451918332MedX SLD Light ClusterMCT10002016-09-24
00628451918356MedX Rehab Portable Laser LCS4502018-10-18
00628451918417SLD Light clusterMCT 5072018-11-06
00628451918103MedX Rehab Console System31102016-09-24

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