510(k) DEN180008
- Device
- MolecuLight i:X
- Applicant
- MolecuLight, Inc.
- 510(k) number
- DEN180008
- Product code
- QCR
- Decision
- Unknown (DENG)
- Decision date
- 2018-07-31
- Date received
- 2018-02-16
- Regulation
- 878.4165
- Classification name
- Wound Autofluorescence Imaging Device
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 1
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Jeffrey K. Shapiro
- Address
- 101 College St., Suite 200 Toronto CA M5G1L7 M5G1L7
FDA Registration Numbers#
- 2431764
- 3018781093
- 3013443304
Source Documents#
510(k) summary PDF not indicated by FDA