Lumenis Stellar M22

K193500 (Lumenis, Ltd., 2020)

The subject Stellar M22 has connection capability with the following available treatment handpieces, for multi-application treatment options. All handpieces are designed for aesthetic and dermatological skin procedure applications, as follows:  The Intense Pulsed Light (IPL) handpiece with a spectrum of 400-1200 nm (with 9 different filters) is indicated for: o Benign epidermal lesions, including dyschromia, hyperpigmentation, melasma, and ephelides (freckles) o Cutaneous lesions, including warts, scars and striae o Benign cutaneous vascular lesions, including port wine stains, hemoangiomas, facial, truncal and leg telangiectasias, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations o Removal of unwanted hair and to effect stable long term, or permanent* hair reduction in skin types I-V through selective targeting of melanin in hair follicles o Mild to moderate inflammatory Acne (Acne vulgaris)  The Nd:YAG Laser handpiece with a wavelength of 1064 nm (Multi-Spot Nd:YAG) is indicated for: o The coagulation and hemostasis of vascular lesions and soft tissue, including the treatment and clearance of superficial and deep telangiectasias (venulectasias) and reticular veins (0.1-4.0 mm. diameter) of the leg o The removal of unwanted hair and to effect table long term, or permanent* hair reduction in skin types I-V through selective targeting of melanin in hair follicles o The non-ablative treatment of facial wrinkles  ResurFX module and handpiece, with wavelength of 1565 nm, is indicated for: o Use in dermatological procedures requiring fractional skin resurfacing and0684 coagulation of soft tissue  The Q-Switched Nd:YAG Laser Handpiece with a wavelength of 1064 nm is indicated for: o Removal of dark tattoos o Treatment of pigmented lesions *Note Permanent hair reduction is defined as long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after completion of treatment regime.

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

K250809 (Lumenis Be, Ltd., 2025)

The Lumenis Stellar M22 system has connection capability with the following available treatment modules, for multi-application treatment options. All modules are designed for aesthetic and dermatological skin procedure application, as follows: ● IPL with a spectrum of 400-1200nm (with different filters) is indicated for: o Benign epidermal lesions, including dyschromia, hyperpigmentation, melasma and ephelides (freckles). o Cutaneous lesions, including warts, scars and striae. o Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations.K250809 Stellar M22 for Intense Pulsed Light (IPL) and Laser system Lumenis Be, Ltd. o Removal of unwanted hair from all skin types, and to effect stable long term, or permanent hair reduction* in skin types I-V through selective targeting of melanin in hair follicles. o Mild to moderate inflammatory Acne (Acne Vulgaris). ● Multi-Spot Nd:YAG Laser, with a wavelength of 1064 nm is indicated for: o The coagulation and hemostasis of vascular lesions and soft tissue, including the treatment and clearance of superficial and deep telangiectasias (venulectasias) and reticular veins (0.1 - 4.0 mm diameter) of the leg. o The non-ablative treatment of facial wrinkles. o The removal of unwanted hair from all skin types, and to effect stable long term, or permanent hair reduction* in skin types I-V through selective targeting of melanin in hair follicles. ● The 1565nm ResurFX module, with a wavelength of 1565 nm, is indicated for: o Use in dermatological procedures requiring skin resurfacing and coagulation of soft tissue. ● Q-Switched Nd:YAG Laser, with a wavelength of 1064 nm, is indicated for: o Treatment of pigmented lesions. o Removal of dark tattoos. (*) Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regimen. Stellar M22 for Intense Pulsed Light (IPL) and Laser system Lumenis Be, Ltd.

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

DEN200028

Universal IPL with a spectrum of 400-1200nm (with different filters) is indicated for: Improvement of signs of Dry Eye Disease (DED) due to Meibomian Gland Dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye, in patients 22 years of age and older with moderate to severe signs and symptoms of DED due to MGD and with Fitzpatrick skin types I-IV. IPL is to be applied only to skin on the malar region of the face, from tragus to tragus including the nose (eyes should be fully covered by protective eyewear). IPL is intended to be applied as an adjunct to other modalities, such as meibomian gland expression, artificial tear lubricants and warm compresses.

Verbatim from the FDA De Novo decision summary, retrieved 8 Sep 2026.