MedX Oralase Portable Laser

GUDID 00628451918196

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.

MedX Health Corp

Musculoskeletal/physical therapy laser, professional
Primary Device ID00628451918196
NIH Device Record Keyd675422a-719c-4874-b1d8-56f4b2095b3e
Commercial Distribution StatusIn Commercial Distribution
Brand NameMedX Oralase Portable Laser
Version Model Number0910
Company DUNS202128257
Company NameMedX Health Corp
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1 905 670 4428
Emailtobillo@medxhealth.com
Phone1 905 670 4428
Emailtobillo@medxhealth.com
Phone1 905 670 4428
Emailtobillo@medxhealth.com
Phone1 905 670 4428
Emailtobillo@medxhealth.com
Phone1 905 670 4428
Emailtobillo@medxhealth.com
Phone1 905 670 4428
Emailtobillo@medxhealth.com
Phone1 905 670 4428
Emailtobillo@medxhealth.com
Phone1 905 670 4428
Emailtobillo@medxhealth.com
Phone1 905 670 4428
Emailtobillo@medxhealth.com
Phone1 905 670 4428
Emailtobillo@medxhealth.com
Phone1 905 670 4428
Emailtobillo@medxhealth.com
Phone1 905 670 4428
Emailtobillo@medxhealth.com
Phone1 905 670 4428
Emailtobillo@medxhealth.com
Phone1 905 670 4428
Emailtobillo@medxhealth.com
Phone1 905 670 4428
Emailtobillo@medxhealth.com
Phone1 905 670 4428
Emailtobillo@medxhealth.com
Phone1 905 670 4428
Emailtobillo@medxhealth.com
Phone1 905 670 4428
Emailtobillo@medxhealth.com
Phone1 905 670 4428
Emailtobillo@medxhealth.com
Phone1 905 670 4428
Emailtobillo@medxhealth.com
Phone1 905 670 4428
Emailtobillo@medxhealth.com
Phone1 905 670 4428
Emailtobillo@medxhealth.com
Phone1 905 670 4428
Emailtobillo@medxhealth.com
Phone1 905 670 4428
Emailtobillo@medxhealth.com
Phone1 905 670 4428
Emailtobillo@medxhealth.com
Phone1 905 670 4428
Emailtobillo@medxhealth.com
Phone1 905 670 4428
Emailtobillo@medxhealth.com
Phone1 905 670 4428
Emailtobillo@medxhealth.com
Phone1 905 670 4428
Emailtobillo@medxhealth.com
Phone1 905 670 4428
Emailtobillo@medxhealth.com

Device Dimensions

Weight190 Gram
Weight190 Gram
Weight190 Gram
Weight190 Gram
Weight190 Gram
Weight190 Gram
Weight190 Gram
Weight190 Gram
Weight190 Gram
Weight190 Gram

Operating and Storage Conditions

Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 149 Degrees Fahrenheit
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 149 Degrees Fahrenheit
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 149 Degrees Fahrenheit
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 149 Degrees Fahrenheit
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 149 Degrees Fahrenheit
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 149 Degrees Fahrenheit
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 149 Degrees Fahrenheit
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 149 Degrees Fahrenheit
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100628451918196 [Direct Marking]
GS100628451918202 [Primary]
GS100628451918219 [Primary]
GS100628451918349 [Primary]
GS120628451918206 [Package]
Contains: 00628451918202
Package: shipping carton box [2 Units]
In Commercial Distribution
GS120628451918213 [Package]
Contains: 00628451918219
Package: shipping carton box [2 Units]
In Commercial Distribution
GS130628451918203 [Package]
Contains: 00628451918202
Package: shipping carton box [3 Units]
In Commercial Distribution
GS130628451918210 [Package]
Contains: 00628451918219
Package: shipping carton box [3 Units]
In Commercial Distribution
GS140628451918200 [Package]
Contains: 00628451918202
Package: shipping carton box [4 Units]
Discontinued: 2019-02-05
Not in Commercial Distribution
GS150628451918207 [Package]
Contains: 00628451918202
Package: shipping carton box [5 Units]
In Commercial Distribution
GS150628451918214 [Package]
Contains: 00628451918219
Package: shipping carton box [5 Units]
In Commercial Distribution
GS160628451918204 [Package]
Contains: 00628451918202
Package: shipping carton box [6 Units]
Discontinued: 2019-02-05
Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ILYLamp, Infrared, Therapeutic Heating

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number9
Public Version Date2019-05-07
Device Publish Date2016-09-24

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