Duns Number:436887608
Device Description: The ASA LASER SH1 device is a medical device for carrying out therapy in the treatment of The ASA LASER SH1 device is a medical device for carrying out therapy in the treatment of musculotendinous and joint pathologies with Nd:YAG laser sources.
Catalog Number
M077H3
Brand Name
SH1
Version/Model Number
M077H3
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
K122125
Product Code
ILY
Product Code Name
Lamp, Infrared, Therapeutic Heating
Public Device Record Key
14a2fb95-20e5-4ab8-bb89-e27e45cb0a2b
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
September 13, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 46 |