Duns Number:202822052
Device Description: The MolecuLight i:X is a handheld imaging tool that allows clinicians diagnosing and treat The MolecuLight i:X is a handheld imaging tool that allows clinicians diagnosing and treating skin wounds, at the point of care, to:(i) View and digitally record images of a wound,(ii) Measure and digitally record the size of a wound, and(iii) View and digitally record images of fluorescence emitted from a wound when exposed to an excitation light.The fluorescence image, when used in combination with clinical signs and symptoms, has been shown to increase the likelihood that clinicians can identify wounds containing bacterial loads >10^4 CFU per grams as compared to examination of clinical signs and symptoms alone. The MolecuLight i:X device should not be used to rule-out the presence of bacteria in a wound.
Catalog Number
-
Brand Name
MolecuLight i:X System
Version/Model Number
1153-11
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
K191371,K210882
Product Code
FXN
Product Code Name
Tape, Camera, Surgical
Public Device Record Key
748832fa-3512-42c0-a424-afc6d677b873
Public Version Date
January 12, 2022
Public Version Number
1
DI Record Publish Date
January 04, 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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |