Duns Number:066550444
Device Description: Portable, battery powered laser therapy device emitting up to 1 W at 635/808nm in CW or pu Portable, battery powered laser therapy device emitting up to 1 W at 635/808nm in CW or pulsed modes.
Catalog Number
-
Brand Name
LZ30
Version/Model Number
LZ30-ProX
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
K123474
Product Code
ILY
Product Code Name
Lamp, Infrared, Therapeutic Heating
Public Device Record Key
7522e059-48f5-4c2b-bd27-ddd6855dc9a2
Public Version Date
March 11, 2022
Public Version Number
1
DI Record Publish Date
March 03, 2022
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. | 9 |