MolecuLight, Inc.: FDA clearances and approvals
MolecuLight, Inc. has 4 FDA 510(k) clearances (first 2019, latest 2022), plus 1 De Novo decision, across 2 product codes in 1 review panel. Median 510(k) review time: 124 days. Since 2017 its median was 124 days, against 196 days for all cleared 510(k)s in the same product codes. It is the industry lead sponsor of 5 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2019 | 1 | 196 |
| 2020 | 0 | — |
| 2021 | 2 | 60 |
| 2022 | 1 | 160 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, MolecuLight, Inc.'s cleared 510(k)s took a median 124 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 196 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QJF | Autofluorescence Imaging Adjunct Tool For Wounds | 4 | 4 |
| QCR | Wound Autofluorescence Imaging Device | 1 | 0 |
Review panels
Most recent MolecuLight, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K213840 | MolecuLight I:X | QJF | 2022-05-18 | 160 |
| K211901 | MolecuLightDX | QJF | 2021-07-21 | 30 |
| K210882 | MolecuLight I:X | QJF | 2021-06-22 | 89 |
| K191371 | MolecuLight i:X | QJF | 2019-12-04 | 196 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN180008 | De Novo | Wound Autofluorescence Imaging Device | 2018-07-31 |
Recalls
openFDA lists no recalls under a recalling firm named MolecuLight, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
MolecuLight, Inc. is the industry lead sponsor of 5 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT06682923: MolecuLightDX Measurement Feature Clinical Validation (Recruiting, started 2024-10-23)
- NCT05196880: Biofilm Correlation and Validation (Completed, started 2022-02-15)
- NCT03754426: A Prospective, Pilot Evaluation of Device Equivalence (Completed, started 2018-11-26)
- NCT03091361: Post Market Clinical Followup of MolecuLight i:X's PPV to Predict Presence of Bacteria in Wounds (Completed, started 2016-06)
- NCT02682069: Positive Predictive Value of the MolecuLight i:X Imaging Device to Predict the Presence of Bacteria in Chronic Wounds (Completed, started 2016-02)
Frequently asked questions
How many FDA 510(k) clearances does MolecuLight, Inc. have?
MolecuLight, Inc. has 4 FDA 510(k) clearances (first 2019, latest 2022), plus 1 De Novo decision, across 2 product codes in 1 review panel.
How long does FDA take to clear MolecuLight, Inc.'s 510(k)s?
The median time from FDA receipt to decision across MolecuLight, Inc.'s cleared 510(k)s is 124 days. Since 2017: 124 days, versus 196 days for all cleared 510(k)s in the same product codes.
What devices does MolecuLight, Inc. make?
Its most frequent FDA product codes are QJF (Autofluorescence Imaging Adjunct Tool For Wounds, 4); QCR (Wound Autofluorescence Imaging Device, 1).
Has MolecuLight, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching MolecuLight, Inc. Related entities may recall under other names.
Next steps
- See all 4 MolecuLight, Inc. clearances with predicates and recalls
- Run predicate analysis for product code QJF, MolecuLight, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.