FDA 510(k)
FDA class 1
Unknown
🇨🇦 Canada
MolecuLight i:X
K Number: DEN180008
·
Decision Jul 31, 2018
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
0
Applicant Total
5
Review Days
165
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MolecuLight i:X
- K Number
- DEN180008
- Device Class
- FDA class 1
- Clearance Type
- Direct
- Regulation Number
- 878.4165
- Medical Specialty
- General, Plastic Surgery
- Decision
- Unknown
- Applicant
- MolecuLight, Inc.
- Date Received
- February 16, 2018
- Decision Date
- July 31, 2018
- Product Code
- QCR
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QCR | Wound Autofluorescence Imaging Device | FDA class 1 | General, Plastic Surgery |