MIRIA Laser Receives FDA Approval for Acne Scarring for All Skin Types

MIRIA Laser Receives FDA Approval for Acne Scarring for All Skin Types featured image
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Acne can be a world-altering struggle no matter what age or stage of life you’re dealing with the chronic skin condition. But the effects of acne on self-confidence last far beyond the poorly-timed active breakout. Acne scarring is one of the most prevalent skin concerns amongst patients with all skin types and tones. For years, the treatments for battling the pitting and post-blemish pigmentation were not versatile enough to be used across all skin types, making finding an acne scarring solution difficult, particularly for patients of color. That all changed this week, though, as the renowned MIRIA laser by AVAVA received FDA approval for treatment of acne scarring across all skin types and tones.

MIRIA by AVAVA Is FDA-Approved for Treating Acne Scars on All Skin Types and Tones

Laser use on darker skin tones has been a tricky topic for patients of color for years, as options for tone-evening and complexion-clearing lasers were often not suitable for safely treating melanated skin. This week, though, AVAVA’s MIRIA laser received a revolutionary FDA 510 (k) approval for the treatment of acne scarring across all Fitzpatrick skin types (I–VI). The approval marked AVAVA’s first formal clinical indication with “several more under consideration,” the brand said. “Acne scarring affects millions and often comes with limited treatment options—particularly for patients with darker skin tones,” the brand explained in a press release for the approval. “AVAVA’s technology directly addresses this gap with a nonablative approach that delivers deep, targeted energy while sparing surrounding tissue.”

To test MIRIA for safe and effective acne scarring reduction across all Fitzpatrick scale skin tones, AVAVA conducted a study with 47 participants who were 21 to 72 years old. 75 percent identified as African American, Asian or Hispanic/Latino. Through their trials, AVAVA found that a whopping 90.2 percent of subjects experienced “visible improvement in their acne scarring” post-treatment, with 87 percent receiving treatments “at or above 120mJ, with energies up to 150mJ—only possible with AVAVA’s proprietary technology.” Plus, post-MIRIA treatment, the study found that “side effects such as redness and swelling were mild and resolved within a few days using standard post-care.”

Why Dermatologists Love MIRIA for Acne Scarring

Aside from the exciting research findings associated with this new clinical indication, dermatologists can’t get enough of MIRIA and are thrilled by the new FDA approval. “AVAVA enables the delivery of higher energies directly into the dermis—levels that were previously unattainable—by precisely sparing the epidermis,” says Fort Lauderdale dermatologist Matthew Elias, MD. “This initiates remodeling of fibrotic scar tissue through new collagen formation, leading to visible improvements in the depth and texture of atrophic scars with minimal surface disruption.” Dr. Elias says that the device’s versatile, cross-skin technology is “truly revolutionary” and “one of the first new innovations in lasers in many years,” but he does expect “many future indications like the FDA clearance for acne scars” soon.

New York dermatologist Marina Peredo, MD, emphasizes the importance of this new indication, explaining, “Acne is the most common skin condition in the U.S., affecting up to 50 million people annually. Globally, it ranks as the eighth most prevalent disease, impacting 9.4 percent of the population.” Not only does acne impact millions of people worldwide, but Dr. Peredo also says that acne scarring is “a frequent consequence,” with 43 percent of patients showing signs of acne scarring, even in mild to moderate cases. “Post-inflammatory hyperpigmentation (PIH) affects 65 percent of Black and 53 percent of Hispanic acne patients (JAAD), and acne prevalence is highest among African Americans at 37 percent, underscoring the need for treatment solutions that address all skin tones,” she says.

Fresno, CA dermatologist Dr. Rohini Shantharam, MD adds, “Acne scarring is notoriously difficult to treat and often requires multiple sessions with various technologies to see even modest improvement, especially when aiming for minimal downtime.” Dr. Shantharam highlights, “Traditional aggressive options like ablative CO2 or Erbium lasers can yield dramatic results, but come with significant recovery.” She loves AVAVA for a “balanced alternative” that creates real results without the downtime.

before and after MIRIA laser
Courtesy of Dr. Shantharam
before and after MIRIA laser
Courtesy of Dr. Shantharam

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