# K213840: MolecuLight I:X

- Pathway: 510(k) (Traditional)
- Applicant: MolecuLight, Inc.
- Decided: May 18, 2022 after 160 days
- Product code: QJF (Autofluorescence Imaging Adjunct Tool For Wounds)
- Device class: 2
- Regulation: 21 CFR 878.4550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to DEN170092 (2018). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210882: MolecuLight I:X, MolecuLight, Inc. (2021) Summary page 5.
- K191371: MolecuLight i:X, MolecuLight, Inc. (2019) Summary page 6.

## Indications for use
The MolecuLight i:X is a handheld imaging tool that allows clinicians diagnosing and treating skin wounds, at the point of care, to (i) View and digitally record images of a wound, (ii) Measure and digitally record the size of a wound, and (iii) View and digitally record images of fluorescence emitted from a wound when exposed to an excitation light. The fluorescence image, when used in combination with clinical signs and symptoms, has been shown to increase the likelihood that clinicians can identify wounds containing bacterial loads >10~4 CFU per gram) as compared to examination of clinical signs and symptoms alone. The MolecuLight i:X device should not be used to rule-out the presence of bacteria in a wound. The MolecuLight i:X does not diagnose or treat skin wounds.

Source page: https://510kreport.com/device/K213840
Methodology: https://510kreport.com/methodology