FDA.reportPublic FDA data

MedX Oralase Portable Laser

Primary DI
00628451918196
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
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
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
20628451918213PackageGS12In Commercial Distribution
30628451918203PackageGS13In Commercial Distribution
30628451918210PackageGS13In Commercial Distribution
40628451918200PackageGS14Not in Commercial Distribution
50628451918207PackageGS15In Commercial Distribution
50628451918214PackageGS15In Commercial Distribution
60628451918204PackageGS16Not in Commercial Distribution
00628451918202PrimaryGS10
00628451918219PrimaryGS10
00628451918349PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628451918196006284519181966284519181960628451918196
2062845191820620628451918206
2062845191821320628451918213
3062845191820330628451918203
3062845191821030628451918210
4062845191820040628451918200
5062845191820750628451918207
5062845191821450628451918214
6062845191820460628451918204
00628451918202006284519182026284519182020628451918202
00628451918219006284519182196284519182190628451918219
00628451918349006284519183496284519183490628451918349

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
Weight190Gram

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 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
00628451918226MedX Rehab Portable Laser09152016-09-24

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