510(k) K213840
K213840 is an FDA 510(k) premarket notification submitted by MolecuLight, Inc. for the device "MolecuLight I:X". The FDA issued a decision of Substantially Equivalent on May 18, 2022. The device falls under product code QJF (Autofluorescence Imaging Adjunct Tool For Wounds), a Class II device regulated under 21 CFR 878.4550. MolecuLight, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 18, 2022
- Date Received
- December 9, 2021
- 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.