Inclusion Criteria:

• Ages 18 years of age to 65 years.

• Has been assessed at the General Internal Medicine Fibromyalgia & Chronic Fatigue Clinic within 12 months of study start (signing consent).

• Has a diagnosis of fibromyalgia (per ACR2016 criteria).

• Has at least 11 tender points (per 1990 criteria).

• Self-reported pain intensity as reported at baseline of 4 or above on the VAS scale (PROMIS Numeric Rating Scale).

• Is on stable medications (unchanged for the 4 weeks prior to study start – signing consent-).

• Is able to participate fully in all aspects of the study.

• Can understand and sign the study informed consent.

• Apart from fibromyalgia and tender point pain, the individual is considered in good health based on assessment by the clinical investigators.

Exclusion Criteria: 

• Used new pain medications (excluding NSAIDs or acetaminophen) or received pain treatment within three days before enrollment.

• Has an implanted device (including a lap band) in the targeted area of laser acupuncture

• Has used an investigational drug within 30 days of study enrollment.

• Reports being pregnant, lactating, or of child-bearing potential at the start of the study (signing consent) or are likely to become pregnant during the laser acupuncture treatment phase (please note:    Pregnancy testing is available upon request for study participants).

• Has a history of any major cardiovascular events, including heart valve disease, ongoing angina, cardiac arrhythmias, congestive heart failure, acute coronary syndrome, stroke, transient ischemic attack, or peripheral vascular disease.

• Has clinically significant acute or chronic progressive or unstable neurologic, hepatic, renal, cardiovascular, lymphatic, respiratory, metabolic disease (such as uncontrolled type 2 diabetes)

• Has a diagnosis of psychiatric disorders such as psychosis, bipolar disorder, or schizophrenia

• Has active cancer, actively receiving treatment for cancer or within 1 year of cancer remission.

• Has had surgical intervention for pain within 1 month prior to enrollment.

• Has an active infection, wound or other external trauma to the areas to be treated with the laser.

• Has a known photosensitivity disorder.

• Has a known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder adherence.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 02/23/2026. Questions regarding updates should be directed to the study team contact.