Duns Number:202128257
Device Description: The Acupuncture Portable Laser delivers high-quality auricular laser acupuncture therapy. The Acupuncture Portable Laser delivers high-quality auricular laser acupuncture therapy. The device features one GaAIAs near-infrared laser diode and three visible red LEDs and a special fiber optic light guide tip that deliver low level laser & light therapy to very small trigger points on the ear. The Acupuncture Portable Laser has been designed for licensed or certified healthcare professionals.
Catalog Number
-
Brand Name
MedX Acupuncture Portable Laser
Version/Model Number
0912
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
Product Code
ILY
Product Code Name
Lamp, Infrared, Therapeutic Heating
Public Device Record Key
ddd0ce7a-d3f2-47b5-ad8e-c375db0ad2be
Public Version Date
May 07, 2019
Public Version Number
7
DI Record Publish Date
September 24, 2016
Package DI Number
50628451918214
Quantity per Package
5
Contains DI Package
00628451918219
Package Discontinue Date
-
Package Status
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 |