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Laser

MIRIA by AVAVA Focal Point Laser

Conical 1550-nm coagulation zones for epidermal-sparing scar and wrinkle resurfacing

시술 시간
30-60분 (範囲・表面麻酔시간で変動)
다운타임
1-3일程度 (色素変化は長引くことあり)
권장 횟수
1-6회 (研究平均3.3회、3-6주 간격)

이 치료에 대해

MIRIA / the AVAVA Skin Treatment System is a US-developed 1550-nm non-ablative fractional laser that scans depth-adjustable, conical coagulation zones within the dermis. Its Focal Point Technology differs from conventional cylindrical microthermal columns and is designed to deliver energy deeper while selectively limiting epidermal thermal exposure. Sapphire contact cooling supports treatments for acne scars, fine lines, wrinkles, and skin resurfacing.

In the United States, the system received 510(k) clearance for acne scars in April 2025 and for fine lines and wrinkles in October 2025. Product-specific peer-reviewed evidence includes mechanistic histology, a prospective single-arm acne-scar study, and a retrospective multicenter wrinkle study. None is a randomized comparative trial and long-term data remain limited, so superiority over established lasers and equal efficacy across every indication should not be assumed.

작용 기전

Scanned micro-pulses from a 1550-nm erbium-glass fiber laser are focused into conical thermal-coagulation zones at selected depths, including approximately 200-400 μm superficially and 700-1300 μm more deeply in the published protocol. Preserved tissue around the zones and partial epidermal sparing support wound healing, fibroblast activity, and collagen remodeling. The cooled contact tip limits surface heating before and after each pulse, but pigment risk still varies with energy, density, overlap, recent sun exposure, and skin type.

적응증

여드름주름·잔주름일반 적응증(상세 설명 참고)

기대 효과

In a product-specific prospective multicenter study, 47 participants received 1-6 treatments (mean 3.3). Mean blinded ECCA score improved from 85.6 to 55.3, 90.2% improved by at least 15 points, and investigators rated 78.0% as improved on GAIS. A 2026 retrospective multicenter wrinkle study of 33 participants found mean FWES improvement from 4.48 to 3.36, while blinded reviewers correctly identified 81.8% of post-treatment images. Both studies lacked a comparator and disclosed company relationships. Outcomes are mainly assessed 1-3 months after the final session; long-term durability and superiority over other devices are not established.

임상 근거

제품 고유 / 동료심사
Manstein D, Chan HH, Bhawalkar J, et al. (2025)
Focal point technology: Controlling treatment depth and pattern of skin injury by a novel highly focused laser. J Am Acad Dermatol
해당 연구에서 임상적 개선이 보고되었습니다(자세한 내용은 원문 논문 참조).
제품 고유 / 동료심사
Wang JV, Pomerantz H, Tran TN, et al. (2025)
Treating Acne Scars in Fitzpatrick Skin Types I-VI Using a Novel 1550 nm Non-Ablative Resurfacing Laser With Focal Point Technology. J Cosmet Dermatol
해당 연구에서 임상적 개선이 보고되었습니다(자세한 내용은 원문 논문 참조).
제품 고유 / 동료심사
Wang JV, Pomerantz H, Tao J, et al. (2026)
Novel 1550-nm Nonablative Resurfacing Laser With Focal Point Technology Improves Fine Lines and Wrinkles With High Energy Delivery. Dermatol Surg
해당 연구에서 임상적 개선이 보고되었습니다(자세한 내용은 원문 논문 참조).
규제 / 공식 자료
U.S. Food and Drug Administration (2025)
510(k) Summary K250402: AVAVA Skin Treatment System. FDA 510(k) Premarket Notification
해당 연구에서 임상적 개선이 보고되었습니다(자세한 내용은 원문 논문 참조).
규제 / 공식 자료
U.S. Food and Drug Administration (2025)
510(k) Summary K252155: AVAVA Skin Treatment System. FDA 510(k) Premarket Notification
해당 연구에서 임상적 개선이 보고되었습니다(자세한 내용은 원문 논문 참조).
간접 근거 / 기기 클래스
Alexis AF, Coley MK, Nijhawan RI, et al. (2016)
Nonablative Fractional Laser Resurfacing for Acne Scarring in Patients With Fitzpatrick Skin Phototypes IV-VI. Dermatol Surg
해당 연구에서 임상적 개선이 보고되었습니다(자세한 내용은 원문 논문 참조).
간접 근거 / 기기 클래스
American Society for Laser Medicine and Surgery (2026)
ASLMS 2026 Plenary: Emerging Devices. ASLMS 45th Annual Conference Program
해당 연구에서 임상적 개선이 보고되었습니다(자세한 내용은 원문 논문 참조).
제조사 자료
AVAVA (2024)
Launch of MIRIA and Jeisys distribution partnership for Korea and Japan. Manufacturer announcement
해당 연구에서 임상적 개선이 보고되었습니다(자세한 내용은 원문 논문 참조).

위험 및 부작용

Transient erythema, edema, warmth, burning or stinging, pain, dryness, roughness, crusting, acneiform eruption, and post-inflammatory hyperpigmentation or hypopigmentation may occur. Mean pain was 4.4/10 in the product-specific study, and one Fitzpatrick III participant developed prolonged hyperpigmentation requiring treatment. General laser-class risks also include blistering, burns, infection, herpes reactivation, prolonged erythema, scarring, and ocular injury. Recent tanning, melasma tendency, and darker skin require conservative energy and density settings plus strict photoprotection.

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