Duns Number:202128257
Device Description: Molemate is a software management system for the SIAScope that displays five unique views: Molemate is a software management system for the SIAScope that displays five unique views: dermatoscopic, blood supply, pigment, dermal pigment and collagen.The SIAscope is a quick, non-invasive device for imaging skin conditions. It uses a technique known as ‘Spectrophotometric Intracutaneous Analysis’ (SIAscopy) to identify and display graphically the separate components of the skin. SIAscopy uses a digital camera and light (both visible and near-infrared) to investigate the skin’s interior structure.The SIAscope operates by illuminating the skin with LEDs and measuring the intensity of remitted light. The intensity of the illumination is similar to the emission from a typical hand held torch or remote control unit.
Catalog Number
-
Brand Name
MoleMate
Version/Model Number
V
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
K062736,K062736,K062736
Product Code
PSN
Product Code Name
Light Based Imaging
Public Device Record Key
d0ddde97-2bdc-4342-bed4-6ed9d297ba9f
Public Version Date
October 17, 2018
Public Version Number
4
DI Record Publish Date
September 22, 2016
Package DI Number
10628451918032
Quantity per Package
1
Contains DI Package
00628451918035
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |