510(k) K230734
K230734 is an FDA 510(k) premarket notification submitted by Precision Healing, LLC for the device "Multispectral Imager Kit (MSI Kit) (300-00015), Multispectral Imager (MSI) (300-00009)". The FDA issued a decision of Substantially Equivalent on December 5, 2023. The device falls under product code QJF (Autofluorescence Imaging Adjunct Tool For Wounds), a Class II device regulated under 21 CFR 878.4550.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 5, 2023
- Date Received
- March 16, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Autofluorescence Imaging Adjunct Tool For Wounds
- Device Class
- Class II
- Regulation Number
- 878.4550
- Review Panel
- SU
- Submission Type
An autofluorescence detection device for general surgery and dermatological use is an adjunct tool that uses autofluorescence to detect tissues or structures. This device is not intended to provide a diagnosis.