MedX Oralase Portable Laser - The Oralase Portable Portable Laser delivers - MedX Health Corp

Duns Number:202128257

Device Description: The Oralase Portable Portable Laser delivers high-quality laser & light therapy for Orala 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.

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More Product Details

Catalog Number

-

Brand Name

MedX Oralase Portable Laser

Version/Model Number

0910

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K082707,K082707,K082707,K082707,K082707,K082707,K082707

Product Code Details

Product Code

ILY

Product Code Name

Lamp, Infrared, Therapeutic Heating

Device Record Status

Public Device Record Key

d675422a-719c-4874-b1d8-56f4b2095b3e

Public Version Date

May 07, 2019

Public Version Number

9

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

60628451918204

Quantity per Package

6

Contains DI Package

00628451918202

Package Discontinue Date

February 05, 2019

Package Status

Not in Commercial Distribution

Package Type

shipping carton box

"MEDX HEALTH CORP" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 3