Duns Number:004053174
Device Description: MEDICAL - Floor Model Low Level Laser - 3 diodes 17.5mW 635nm - 1 diode 23mW 405nm - IFU MEDICAL - Floor Model Low Level Laser - 3 diodes 17.5mW 635nm - 1 diode 23mW 405nm - IFU Pain Reduction, Acne Reduction
Catalog Number
-
Brand Name
FX405
Version/Model Number
MLS-AC
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
K212595
Product Code
NHN
Product Code Name
Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
Public Device Record Key
2f10c9f1-595a-49c0-8cb9-4ae861164e6c
Public Version Date
December 16, 2021
Public Version Number
3
DI Record Publish Date
August 10, 2020
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |