Views: 222 Author: Becky Publish Time: 2025-01-01 Origin: Site
Content Menu
● Understanding FDA Approval vs. Clearance
● Popular FDA-Cleared Red Light Therapy Devices
>> 1. EZ Therapylight Red Light Therapy FDA Facial Mask
>> 2. Medlight 630 Pro Hand Held Red Light Therapy
>> 3. Prism Light Pod Red Light Therapy Bed
>> 5. dpl® Deep Penetrating Infrared FlexPad Light Therapy System
● Benefits of Red Light Therapy
● How Does Red Light Therapy Work?
● Applications of Red Light Therapy
● How to Choose an FDA-Cleared Device
● Recent Research Developments
>> 1. What conditions can red light therapy treat?
>> 2. How long does it take to see results from red light therapy?
>> 3. Are there any side effects associated with red light therapy?
>> 4. Can I use red light therapy at home?
>> 5. How often should I use red light therapy?
Red light therapy (RLT) has gained significant attention in recent years for its potential therapeutic benefits, including pain relief, skin rejuvenation, and hair growth stimulation. As the popularity of RLT devices grows, understanding which devices are approved or cleared by the U.S. Food and Drug Administration (FDA) is essential for consumers seeking safe and effective treatment options. This article explores the FDA approval process for RLT devices, highlights some popular FDA-cleared devices, and discusses their applications.

The FDA plays a crucial role in regulating medical devices, including those used for red light therapy. It's important to differentiate between "FDA approved" and "FDA cleared."
- FDA Approved: This designation is reserved for higher-risk medical devices that undergo rigorous testing and review to ensure safety and efficacy.
- FDA Cleared: Most RLT devices fall into this category. They undergo a less stringent review process known as the 510(k) process, which determines if the device is substantially equivalent to an existing legally marketed device. This means that while they are considered safe for use, they may not have undergone the same level of scrutiny as approved devices.
Several RLT devices have received FDA clearance for various therapeutic applications. Here are some notable examples:
This over-the-counter device was cleared by the FDA specifically for treating mild to moderate acne using blue and red light therapy.
This handheld device is compact and easy to use, featuring 81 LEDs that emit near-infrared light. It is designed for pain relief and skin healing, making it suitable for localized treatment areas.
The Prism Light Pod offers full-body exposure with over 14,000 LEDs. It delivers therapeutic light at wavelengths of 630nm, 660nm, and 850nm, which can help with pain relief, skin enhancement, wound healing, and muscle recovery in just 15-minute sessions.
The Celluma PRO is a versatile device that combines multiple wavelengths of light to treat acne, aging skin, pain, and hair loss. Its patented shape-taking design allows it to conform to various body parts for effective treatment.
The dpl® FlexPad is designed for targeted pain relief and tissue healing. It utilizes medical-grade red and near-infrared LEDs to enhance circulation, reduce inflammation, and promote collagen production. The device is flexible, allowing it to conform to different body parts for effective treatment.

Red light therapy has been studied for its various health benefits:
- Pain Relief: RLT can help reduce inflammation associated with chronic pain conditions such as arthritis or muscle soreness.
- Skin Health: It promotes collagen production, potentially reducing wrinkles and improving skin texture.
- Wound Healing: RLT has shown promise in enhancing tissue repair and reducing healing time for wounds.
- Hair Growth: Some studies suggest that RLT can stimulate hair follicles and promote regrowth in individuals experiencing hair loss.
Red light therapy works by exposing the skin to low levels of red or near-infrared light. Unlike ultraviolet (UV) light, which can damage the skin, red light therapy is considered safe and beneficial. The process involves:
1. Cellular Energy Production: When mitochondria absorb red light, they become more efficient at producing energy (ATP). This boost in energy can enhance cellular function and regeneration.
2. Increased Blood Flow: RLT promotes better circulation, delivering more oxygen and nutrients to tissues, which aids in faster healing.
3. Reduction of Inflammation: The therapy helps lower oxidative stress by decreasing free radicals in the body, promoting overall health.
4. Collagen Production: By stimulating fibroblasts in the skin, RLT enhances collagen synthesis, leading to improved skin elasticity and reduced signs of aging.
Red light therapy has a wide range of applications across different fields:
- Dermatology: Used for treating acne scars, psoriasis, eczema, and signs of aging like wrinkles and fine lines.
- Physical Therapy: Employed in rehabilitation settings to reduce inflammation and accelerate recovery from injuries.
- Cosmetic Procedures: Often integrated into skincare routines for its rejuvenating effects on the skin.
- Neurology: Emerging research indicates potential benefits in treating conditions like traumatic brain injury (TBI) through transcranial light delivery methods[1].
When considering an RLT device, keep the following factors in mind:
- Purpose: Identify your primary goal—whether it's pain relief, skin rejuvenation, or another application.
- Device Type: Choose between handheld devices for targeted treatment or larger panels/bed systems for full-body exposure.
- Wavelengths: Look for devices that emit specific wavelengths known to be effective for your intended use (typically between 600nm to 850nm).
- User Reviews: Research user experiences and expert recommendations to find a reputable brand.
While red light therapy is generally considered safe when used correctly, there are some precautions:
- Individuals with certain medical conditions (e.g., skin cancer or photosensitivity) should consult a healthcare provider before using RLT.
- Pregnant women should also seek medical advice before starting treatment.
Recent studies continue to expand our understanding of red light therapy's potential applications:
- Traumatic Brain Injury: Research from Birmingham University shows that near-infrared light delivered transcranially can aid recovery after mild traumatic brain injury by reducing inflammation[1].
- Mental Health: Emerging evidence suggests that RLT may help alleviate symptoms of depression by modulating serotonin production[8].
- Myopia Control in Children: Studies indicate that low-level red light therapy may effectively control myopia progression in children[7].
These findings highlight the versatility of red light therapy beyond traditional applications and underscore the need for ongoing research.
Red light therapy presents a promising avenue for various therapeutic applications. With numerous FDA-cleared devices available on the market, consumers have options tailored to their specific needs. Understanding the differences between FDA approval and clearance is crucial in making informed decisions regarding these therapies. Always consult with healthcare professionals before starting any new treatment regimen.

Red light therapy can treat various conditions including chronic pain, skin issues like acne and wrinkles, hair loss, and promote wound healing.
Results can vary based on the condition being treated; however, many users report noticing improvements within a few sessions up to several weeks of regular use.
RLT is generally safe with minimal side effects; however, some users may experience mild redness or irritation at the treatment site.
Yes! Many FDA-cleared RLT devices are designed for home use; just follow the manufacturer's instructions carefully.
Frequency depends on the device and condition being treated; typically sessions range from 2-5 times per week.
[1] https://www.sciencedaily.com/releases/2024/10/241011140804.htm
[2] https://healthcare.utah.edu/the-scope/mens-health/all/2024/06/176-red-light-therapy-just-fad
[3] https://dynamicspinesport.com/blogs/medicine/fda-approved-red-light-therapy/
[4] https://maysama.co/blogs/news/the-latest-research-in-photobiomodulation-2024
[5] https://www.aad.org/public/cosmetic/safety/red-light-therapy
[6] https://www.rehabmart.com/post/red-light-therapy-devices-fda-approved
[7] https://www.healio.com/news/optometry/20241226/top-red-light-therapy-stories-of-2024-report-potential-caution
[8] https://www.gundersenhealth.org/health-wellness/aging-well/exploring-the-benefits-of-red-light-therapy
[9] https://mitoredlight.com
[10] https://www.healthline.com/health/red-light-therapy
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