Alma Harmony

Alma Lasers, Inc.

Country / region:United States (US)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

United States (US)

Product code

GEX
21 CFR 878.4810

Predicate devices

6

Cited as predicate

1

Device details

FDA 510(k) registration fields

K number
K230308
Device name
Alma Harmony
Country / region
United States(US)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2023-02-03
Decision date
2023-03-01
Submission type
Traditional
Technology type
IPL(AI inferred)
Clinical applications
Hair removalSkin resurfacingPigment treatmentVascular treatment
Primary application
Hair removal
Classification source
AI classified

Indications for Use

Iris VL / PL Applicator: Intended for use in aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery, and dermatology. The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles), lentigines, nevi, melasma, and cafe-au-lait macules. The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. Use on all skin types (Fitzpatrick I- VI). Iris Dye VL / Dye SVL Applicator: The treatment of benign pigmented lesions including café-au-lait (macules), lentigines (senile and solar), freckles (ephelides), chloasma, nevi, nevus spillus, nevus of Ota, and Becker's Nevi. The treatment of other pigmented cutaneous lesions including verrucae, skin tags, keratosis, and plaques. The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. Use on skin types (Fitzpatrick I-V). Iris SHR Applicator: The Advanced Fluorescence Technology (AFT) 650-950 nm handpiece (with and without contact-cooling) is indicated for: The treatment of tattoos, the treatment of moderate inflammatory acne vulgaris, the treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles), lentigines, nevi, melasma, and cafe-au-lait, the treatment of cutaneous lesions including warts, scars and striae, the treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. The removal of unwanted hair and to effect stable long-term or permanent hair reduction. Use on all skin types (Fitzpatrick I-VI), including tanned skin. Iris Acne Applicator: Intended for use in aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery and dermatology. The Advanced Fluorescence Technology (AFT) 420-950 nm Acne Module Applicator (with and without contact-cooling) is indicated for: The treatment of moderate inflammatory acne vulgaris. The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles). The treatment of cutaneous lesions including warts, scars and striae. The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, ro

Intended Use

Iris VL / PL Applicator: Intended for use in aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery, and dermatology. The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles), lentigines, nevi, melasma, and cafe-au-lait macules. The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. Use on all skin types (Fitzpatrick I- VI). Iris Dye VL / Dye SVL Applicator: The treatment of benign pigmented lesions including café-au-lait (macules), lentigines (senile and solar), freckles (ephelides), chloasma, nevi, nevus spillus, nevus of Ota, and Becker's Nevi. The treatment of other pigmented cutaneous lesions including verrucae, skin tags, keratosis, and plaques. The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. Use on skin types (Fitzpatrick I-V). Iris SHR Applicator: The Advanced Fluorescence Technology (AFT) 650-950 nm handpiece (with and without contact-cooling) is indicated for: The treatment of tattoos, the treatment of moderate inflammatory acne vulgaris, the treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles), lentigines, nevi, melasma, and cafe-au-lait, the treatment of cutaneous lesions including warts, scars and striae, the treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. The removal of unwanted hair and to effect stable long-term or permanent hair reduction. Use on all skin types (Fitzpatrick I-VI), including tanned skin. Iris Acne Applicator: Intended for use in aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery and dermatology. The Advanced Fluo

Device Description

The Alma Harmony is a Class II Medical Device that combines multiple technologies into one platform for use in dermatologic, aesthetic procedures and pain management procedures. The system is comprised of a micro-processor-controlled and user-friendly console that houses the power supply, the electronics and the user interface. It has 6 applicators that are attached to the console, which can be selected for use in treatment through the user interface. There are 6 separate applicators. Each handpiece has its own indication for use. Iris VL / PL is an IPL handpiece operating in the wavelength range of 540nm-950nm. Iris Dye VL and Dye SVL is an IPL handpiece operating in the wavelength range of 500nm-600nm. Iris SHR is an IPL handpiece that operates in the wavelength range of 650nm-950nm. Iris Acne is an IPL handpiece operating in the wavelength range of 420nm – 950nm. Iris NIR is near infrared with a wavelength of 1300nm. Iris Diode is a 520nm diode laser.

Summary parsed at:2026-06-01 05:32:32 UTC

Predicate devices

6

K230308 references 6 predicate/reference devices

Cited as predicate

1

1 submission cite K230308 as a predicate