Duns Number:010000704
Device Description: Over the counter blue LED phototherapy device for the treatment of acne.
Catalog Number
-
Brand Name
Sapphire
Version/Model Number
S415
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
July 01, 2031
Issuing Agency
In GS1
MRI safety Status
MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
Yes
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OLP
Product Code Name
Over-The-Counter Powered Light Based Laser For Acne
Public Device Record Key
b5ac4d58-e6e7-4e03-97a6-9478cd76c4f5
Public Version Date
July 04, 2022
Public Version Number
1
DI Record Publish Date
June 24, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 10 |