FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
MolecuLight i:X
K Number: K191371
·
Decision Dec 4, 2019
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
5
Applicant Total
4
Review Days
196
Basic Information
- Device Name
- MolecuLight i:X
- K Number
- K191371
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4550
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MolecuLight Inc.
- Date Received
- May 22, 2019
- Decision Date
- December 4, 2019
- Product Code
- QJF
- 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 |
|---|---|---|---|
| QJF | Autofluorescence Imaging Adjunct Tool For Wounds | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QJF), ordered by most recent decision date.
SnapshotGLO (KB100)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Multispectral Imager Kit (MSI Kit) (300-00015), Multispectral Imager (MSI) (300-00009)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MolecuLight I:X
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MolecuLightDX
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MolecuLight I:X
FDA 510(k)
FDA Class 2
·General, Plastic Surgery