Cutera® Announces New FDA Clearances for truFlex® to Support Rehabilitation, Recovery and Muscle Wellness

The next evolution of truFlex fortifies its position as a versatile solution for rehabilitation with new applications in functional strength for the abdomen, arms, calves, glutes and thighs.

BRISBANE, Calif., Dec. 18, 2025 /PRNewswire/ -- CUTERA, INC., a leading provider in aesthetic, dermatological solutions, today announced that the U.S. Food and Drug Administration (FDA) has granted expanded indications for its truFlex muscle stimulation technology. This expanded clearance moves truFlex beyond aesthetic use alone, adding rehabilitative and therapeutic applications and opening new treatment areas for the arms and calves.

"The new truFlex indications reflect a major advancement in how we approach muscle rehabilitation and functional strength. Its precision and customization make it an exceptional modality for supporting patients at every stage of their wellness and rehabilitation journey. I'm energized by what this means for my patients and the meaningful impact it will have in my practice," said Dr. Edward Alvarez, CEO and Founder of Restimulate Health.

The newly expanded indications include:

• Strengthening, toning, and firming of arms and calves
• Relaxation of muscle spasms
• Prevention or retardation of disuse atrophy
• Increasing local blood circulation
• Muscle re-education
• Maintaining or increasing range of motion
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
• Stimulation of neuromuscular tissue for bulk muscle excitation in the legs or arms for rehabilitative purposes
• Adjunctive therapy for the treatment of medical diseases and conditions (to be used under medical supervision)

"Rehabilitation and muscle wellness represent two of the most exciting growth areas in medical technology today. These new clearances mark an important milestone in Cutera's mission to improve the lives of patients through advanced, versatile solutions that address both aesthetic and therapeutic demand," said Taylor Harris, CEO of Cutera. "By extending truFlex's uses into rehabilitation and recovery, we are opening new opportunities for providers to support patients across a broader spectrum of care."

truFlex was introduced to the market in 2019 and is powered by proprietary Multi-Directional Stimulation (MDS) technology to induce controlled muscle contractions in targeted muscle groups by delivering energy through applicators that can be customized to a patient's body shape or targeted treatment area. With this clearance, Cutera can now partner with physicians, rehabilitation specialists, and other providers to deliver expanded benefits that support both patient wellness and clinical outcomes.

For further information on truFlex by Cutera interested providers can visit https://cutera.com/us-en/products/truflex/. Patients who would like to learn more or search for a truFlex provider can visit www.yourtrubody.com.

About Cutera, Inc.
Cutera is a leading provider of aesthetic and dermatology solutions for practitioners worldwide. For over 25 years, Cutera strives to improve lives through medical aesthetic technologies that are driven by science and powered through partnerships. For more information, call 1-888-4-CUTERA or visit Cutera.com.

truFlex Important Safety Information:

Indications for Use: truFlex is indicated for the improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen; strengthening, toning, and firming of arms, buttocks, thighs, and calves; prevention or retardation of disuse atrophy; muscle re-education; stimulation of neuromuscular tissue for bulk muscle excitation in the legs or arms for rehabilitative purposes; to be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions. 

Important Safety Information: The following treatment-related expected transient side effects and possible adverse events may occur during or following treatment with truFlex: Increased heart rate, skin irritation/hypersensitivity, allergic skin reaction, discomfort/pain and muscle soreness, bruising, random muscle contraction, frequent urination/bowel stimulation, increased.

Contraindications: Patients with cardiac pacemakers, defibrillators, or other implanted electronic devices; Metallic implants under the treatment area; Epilepsy; Cancerous lesions; Acute trauma or fracture; Recent surgical procedures; Abdominal or inguinal hernia; Critical ischemia of lower limbs; Blood flow deficiencies/venous thrombosis.

Warnings:  Do not treat the following patients without physician evaluation: Pregnant patients (Safety of stimulation during pregnancy or delivery has not been established); patients with known myocardial arrhythmia, patients who have chronic conditions in the abdomen, gut or intestinal areas (i.e. Crohn's disease, Colitis, Graves' disease, etc.). Do not treat transthoracically (on the chest or upper back). The introduction of electrical current into the heart may cause cardiac arrhythmia. Do not treat transcerebrally (on the head). Do not treat over the face or neck. Severe spasming of the laryngeal and pharyngeal muscles may occur, closing the airway and causing difficulty breathing. Do not treat over swollen, infected, or inflamed areas or skin eruptions (i.e. phlebitis, thrombophlebitis, varicose veins). Do not treat over metallic implants.

Precautions: Use caution when treating patients with suspected or diagnosed heart problems; patients who have a tendency to hemorrhage following acute trauma or fracture; patients following recent surgical procedures when muscle contraction may disrupt the healing process; over the menstruating uterus; over areas of the skin that lack normal sensation. Always keep verbal contact with the patient during therapy. Never leave the patient unattended. Do not use any anesthetic (including inhalation anesthetics) with truFlex procedures. Patient feedback is necessary to determine optimal treatment levels and to help prevent adverse reactions. Topical anesthetics may also damage the handpiece. Reaction to treating over medical implants is unknown. Consult with the implant manufacturer or prescribing physician before determining if the patient is a candidate for treatment.

Patients with abdominal or inguinal hernias are contraindicated for treatment. In addition, caution should be given to patients who have had hernia repair or patients who have undiagnosed or suspected hernias, as their condition is contraindicated. Patients who have had hernia repair should consult with their physician prior to truFlex treatment. Before administering truFlex treatment, assess patients for potential undiagnosed hernias. An optional Hernia Risk Pre-screening Questionnaire is available onMyCutera.com, or providers may use clinical judgment or alternative methods. Refer patients with identified risk factors to a physician for further evaluation. Treatment should not proceed unless the patient has been medically cleared. Instruct patients to avoid any strenuous exercise or exercise of the treated muscles for 24 hours prior to and after treatment. Older individuals should obtain clearance from a physician before beginning treatment with the truFlex device, similar to starting a new exercise regimen. Older individuals may be more susceptible to underlying conditions (e.g., hernias, cardiac arrhythmia, or other health concerns) that maybe contraindicated or require additional medical evaluation prior to treatment.

Please consult your Healthcare Provider when using truFlex for rehabilitation and recovery, individual results and experiences may vary.

Contacts
Media:
EvolveMKD
[email protected]

SOURCE Cutera