FDA.reportPublic FDA data

MedX Oralase Portable Laser

Primary DI
00628451918202
Brand
MedX Oralase Portable Laser
Company
MedX Health Corp
Model
0910
Device description
The Oralase Portable Portable Laser delivers high-quality laser & light therapy for Oralase applications.The laser can be used in a variety of procedures to reduce pain, swelling, bleeding, bruising and other conditions. The device features one GaAIAs near-infrared laser diode and three visible red guide LEDs that deliver laser & light therapy. The Oralase Portable Laser 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

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
K082707000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082707000MEDX LPT 200 TETHERED LASER & MEDX LPS 200 (ORALASE) PORTABLE LASERMedx Electronics, Inc.2008-10-01ILY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00628451918196Direct MarkingGS10
20628451918206PackageGS12In Commercial Distribution
30628451918203PackageGS13In Commercial Distribution
40628451918200PackageGS14Not in Commercial Distribution
50628451918207PackageGS15In Commercial Distribution
60628451918204PackageGS16Not in Commercial Distribution
00628451918202PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628451918196006284519181966284519181960628451918196
2062845191820620628451918206
3062845191820330628451918203
4062845191820040628451918200
5062845191820750628451918207
6062845191820460628451918204
00628451918202006284519182026284519182020628451918202

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), 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.

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

Contacts#

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

Regulatory Flags#

DUNS number
202128257
Device count
1
Kit
true
Serial number
true

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
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
00628451918226MedX Rehab Portable Laser09152016-09-24
00628451918103MedX Rehab Console System31102016-09-24

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