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.
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
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
ILY
Product Code Name
Lamp, Infrared, Therapeutic Heating
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
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
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 3 |