FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
MolecuLight I:X
K Number: K213840
·
Decision May 18, 2022
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
6
Applicant Total
5
Review Days
160
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Basic Information
- Device Name
- MolecuLight I:X
- K Number
- K213840
- 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
- December 9, 2021
- Decision Date
- May 18, 2022
- 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 |
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