510(k) DEN180008
DEN180008 is an FDA 510(k) premarket notification submitted by MolecuLight, Inc. for the device "MolecuLight i:X". The FDA issued a decision of De Novo Granted on July 31, 2018. The device falls under product code QCR (Wound Autofluorescence Imaging Device), a Class I device regulated under 21 CFR 878.4165. MolecuLight, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- July 31, 2018
- Date Received
- February 16, 2018
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Wound Autofluorescence Imaging Device
- Device Class
- Class I
- Regulation Number
- 878.4165
- Review Panel
- SU
- Submission Type
A wound autofluorescence imaging device is a tool to view autofluorescence images from skin wounds that are exposed to an excitation light. The device is not intended to provide quantitative or diagnostic information.