Sciences & Sources

Somalux shares evidence-based education on photobiomodulation (PBM/LLLT) and related wellness modalities. This page lists selected public sources we use when we describe mechanisms (e.g., mitochondria/ATP, nitric oxide signaling) and when we reference device regulatory listings (e.g., FDA 510(k) clearances).

Note: Somalux does not diagnose, treat, or cure disease. Information is educational and intended to support informed conversations with licensed clinicians.

Many PBM/LLLT devices are regulated as Class II medical devices and may be “510(k) cleared” (marketing clearance), which is different from “FDA approval.” (FDA Access Data)

Sciences & Sources

FDA (official) – 510(k) database and examples
- FDA 510(k) Premarket Notification search/result example (Erchonia SHL, K142042):
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K142042
- FDA 510(k) decision summary PDF (Erchonia EVRL, K191257):
https://www.accessdata.fda.gov/cdrh_docs/pdf19/K191257.pdf
- FDA 510(k) decision summary PDF (Erchonia XLR8, K211186):
https://www.accessdata.fda.gov/cdrh_docs/pdf21/K211186.pdf
- FDA 510(k) decision summary PDF (Erchonia FX-405, K212595):
https://www.accessdata.fda.gov/cdrh_docs/pdf21/K212595.pdf
- FDA 510(k) decision summary PDF (Erchonia FX 635, K190572):
https://www.accessdata.fda.gov/cdrh_docs/pdf19/K190572.pdf
Erchonia (vendor statements – cite as “Erchonia states…”)
- “We own 22 of the 25 FDA-clearances given to Low-Level Lasers…” (Erchonia EMEA page):
https://erchonia-emea.com/low-level-laser-therapy-devices/
PBM mechanisms – mitochondria / cytochrome c oxidase / nitric oxide (open access where possible)
- “Light, Cytochrome C Oxidase, and Nitric Oxide—Review…” (PMC full text):
https://pmc.ncbi.nlm.nih.gov/articles/PMC7495914/
- “Nitric oxide and a novel function of mitochondrial cytochrome c oxidase…” (PubMed):
https://pubmed.ncbi.nlm.nih.gov/21356170/
- “Photobiomodulation and nitric oxide signaling” (PMC full text):
https://pmc.ncbi.nlm.nih.gov/articles/PMC9808891/
- “Irradiance-dependent changes… nitric oxide… cytochrome c oxidase hypothesis” (PubMed):
https://pubmed.ncbi.nlm.nih.gov/32790251/

Brain PBM / network studies (optional but strong for “neuronal modulation” wording)
- “Transcranial photobiomodulation-induced changes in human brain networks…” (PMC full text):
https://pmc.ncbi.nlm.nih.gov/articles/PMC7587286/
- 2025 MEG/EEG connectivity paper (Frontiers full text):
https://www.frontiersin.org/journals/human-neuroscience/articles/10.3389/fnhum.2025.1704482/full
- 2023 review “Transcranial photobiomodulation with near-infrared light”:
https://journals.lww.com/nrronline/fulltext/2023/09000/transcranial_photobiomodulation_with_near_infrared.15.aspx