Alma Harmony (2023 gen)

K230308 (Alma Lasers, Inc., 2023)

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.

Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.

K233024 (Alma Lasers, Inc., 2024)

The Alma Harmony is intended for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic surgery (dermatology and plastic surgery). Clear Skin Pro 1540nm Applicator: The ClearSkin Pro 1540nm is indicated for : Use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue. SupErb 2940nm Applicator: The 2940 nm Er:YAG Laser Module handpiece with standard and scanner accessory tips (with and without contactcooling) is indicated for use in soft tissue (skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs, and glands. Dermatology and Plastic Surgery: Skin resurfacing, Treatment of wrinkles, Epidermal nevi, Telangiectasia, Spider veins, Actinic chelitis, Keloids, Verrucae, Skin tags, Anal tags, keratoses, Scar revision (including acne scars), Debulking benign tumors, Debulking cysts, Superficial skin lesions, Diagnostic biopsies, Decubitus ulcers. General Surgery: Surgical incision/excision, vaporization, ablation, and coagulation of soft tissue where skin incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue ablation, and/or vessel coagulation may be indicated. Genitourinary: Treatment of: Lesions of the external genitalia, urethra and anus, penis, scrotum, and urethra (includes condyloma acuminate, giant perineal condyloma, and verrucous carcinoma), vulvar, lesions, polyps, and familiar polyps of the colon. Gynecology: Treatment of: Cervical intraepithelial neoplasia (CIN), herpes simplex, endometrial adhesions, cysts, and condyloma. Oral/Maxiofacial: Treatment of: Benign oral tumors, oral and glossal lesions, and gingivectomy. Otorhrynolaringology / Head and Neck (ENT): Treatment of: Ear, nose and throat lesions, polyps, cysts, hyperkeratosis, Excision of carcinogenic tissue and oral leukoplakia. Ophthalmology : Treatment of: Soft tissue surrounding the eye and orbit. Podiatry: Treatment of: Warts, plantar verrucae, large mosaic verrucae, Matrixectomy.

Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.

K243044 (Alma Lasers, Inc., 2025)

1064nm mode is indicated for the removal or lightening of unwanted facial or body hair, for skin resurfacing (ablation of epidermal skin layers) in dermatology and aesthetic surgery, benign pigmented lesions (dermal melanocytosis) and tattoo removal for dark and blue inks. The 1064nm fractional mode is indicated for the treatment of wrinkles in Fitzpatrick Skin Types I-IV. 532 nm mode is indicated for tattoo removal including red, blue and light blue and green inks, for the treatment of benign vascular lesions including telangiectasias, spider angiomas, cherry angiomas, spider nevi and the treatment of benign pigmented lesions including Cafe-au-lait birthmarks, solar lentigines, Becker's nevi, freckles nevus spilus and nevus of ota. 532nm mode is also indicated for incision, excision, ablation and vaporization of soft tissue in general dermatology. The Iris Diode is intended for use for vascular lesions, spider veins, spider naevi, teleangiectasis, red superficial veins of the legs and face, pigmented lesions (e.g. cafe-au-lait stains, lentigo), hemangiomas, port wine stains, rosacea.

Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.