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De Novo DEN180008
- Device
- MolecuLight i:X
- Contact
- jeffrey k. shapiro
- De Novo number
- DEN180008
- Product code
- QCR
- Regulation
- 878.4165
- Classification name
- wound autofluorescence imaging device
- Decision
- granted (DENG)
- Decision date
- 2018-07-31
- Date received
- 2018-02-16
- Classification advisory
- General & Plastic Surgery
- Review advisory
- General & Plastic Surgery
- Type
- Direct
Current FDA Classification#
- Product code
- QCR
- Device name
- Wound Autofluorescence Imaging Device
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation
- 878.4165
- Implant
- N
- Life sustain/support
- N