invisaRed® – Research and FDA Clearance

Clinical Studies

The invisaRed® IR Elite underwent a randomized, double-blind clinical trial (ClinicalTrials.gov identifier NCT03811093) that was reviewed as part of its FDA 510(k) clearance.

According to the manufacturer, participants receiving nine treatments demonstrated average improvements including:

  • Average body fat reduction: 1.75%
  • Average fat loss: 4.53 pounds
  • Average circumference reduction: 10.16 inches
  • No serious adverse reactions reported in the study.

Independent research on low-level laser therapy for body contouring has also shown statistically significant reductions in waist, hip, and abdominal circumference compared with sham treatment in selected populations.

FDA Clearance

The invisaRed® ELITE received FDA 510(k) clearance (K192275) in August 2020 as a Class 3b medical device under the regulation for low-level laser fat-reduction systems.

It’s helpful to distinguish a few regulatory terms:

  • FDA cleared means the FDA determined the device is substantially equivalent to a legally marketed device for its intended use.
  • FDA approved is generally used for higher-risk devices requiring Premarket Approval (PMA) and is not the regulatory pathway used for most Class II aesthetic laser devices.

What Does “Class 3b Medical Laser” Mean?

There are two different “class” systems that are often confused:

1. Medical Device Class (FDA)

The invisaRed® ELITE is a Class 3b medical device, referring to its regulatory category and the level of FDA oversight.

Hazard Level: High risk for eye exposure.

Power Output: Continuous wave lasers ranging from 5 mW to 490–500 mW.

FDA Indication: These devices present an immediate eye hazard if viewed directly or via a reflection off a shiny surface (specular reflection). They are generally safe for the skin when diffused, but a focused, direct beam can present a mild skin exposure hazard or heat up materials. They do not present a fire hazard like Class 4 lasers.

Common Examples: Low-level laser therapy (LLLT) machines, research laboratory equipment, and entertainment light show projectors. [1, 2, 3, 4, 5, 6]

2. Laser Safety Class

Many therapeutic lasers are described by their laser hazard classification (such as Class 3R, Class 3B, or Class 4), which relates to eye and skin safety—not medical effectiveness. Higher hazard classes require additional operator training and protective measures. Our technicians have undergone thorough training and are certified.

Why invisaRed® Is Safe and Effective

InvisaRed® is a non-invasive, FDA-cleared body contouring system that uses low-level red (680 nm) and infrared (980 nm) laser light to support the body’s natural fat-reduction processes. Unlike surgical procedures, InvisaRed does not cut, freeze, or heat tissue to destructive temperatures. Treatments are comfortable, require no needles, no anaesthesia, and no downtime, allowing most people to return to normal activities immediately after their session.

The technology works through photobiomodulation, where specific wavelengths of light stimulate normal cellular activity. This process is intended to encourage fat cells to temporarily release stored lipids, which are then processed naturally by the body’s metabolic and lymphatic systems. When combined with healthy nutrition, hydration, and regular physical activity, many patients experience improvements in body contour and reductions in circumference.

The best candidates are individuals who are close to their ideal weight but have stubborn areas of fat they would like to reduce. Individual results vary, and invisaRed® is designed to complement—not replace—a healthy lifestyle.

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