MTONE EVO (MTONE EVO)

M&T S.R.L.

Country / region:Italy (IT)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

Italy (IT)

Product code

GEX
21 CFR 878.4810

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Device details

FDA 510(k) registration fields

K number
K240604
Device name
MTONE EVO (MTONE EVO)
Company
M&T S.R.L.
Country / region
Italy(IT)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2024-03-04
Decision date
2024-09-20
Submission type
Traditional
Technology type
Diode(AI inferred)
Clinical applications
Vascular treatmentPigment treatment
Primary application
Vascular treatment
Classification source
AI classified

Indications for Use

MTONE EVO and its Hand Pieces are intended for use in aesthetic, surgical and cosmetic applications and in selective treatments required in the medical specialties of dermatology and general and plastic surgery. MTONE EVO with HR808nm and HR808 XL Laser Handpieces are indicated for the treatment of benign vascular lesions, benign pigmented lesions, hair removal and permanent hair reduction. MTONE EVO with HR760/808/1060nm Laser Hand piece is indicated for benign vascular and vascular dependent lesions removal (VL mode: frequency < 9 Hz) and temporary hair reduction (HR In-moving mode: frequency >= 9 Hz). MTONE EVO with AC415-950nm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) is indicated for the treatment of inflammatory acne (acne vulgaris) in skin types (1-V) to the Fitzpatrick scale. MTONE EVO with VLPL535-950 nm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) is indicated for the treatment of benign pigmented and vascular lesions in skin types (1-V) to the Fitzpatrick scale. MTONE EVO with VLPL535-950 nm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) with Sub-Millisecond Technology (S.M.T.) is indicated for the treatment of erythematous rosacea, telangiectasias, PWS (Port Wine Stains), benign pigmented lesions (e.g., mottled pigmentation, ephelides) and benign vascular lesions (e.g., diffuse redness). MTONE EVO with HR580-950 nm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) is indicated for hair removal and permanent hair reduction in all skin types (1-V) to the Fitzpatrick scale. MTONE EVO with SR580-950 nm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) is indicated for treatment of benign pigmented epidermal and cutaneous lesions including warts, scars and striae in all skin types (I-VI) to the Fitzpatrick scale. MTONE EVO with HR635-950 nm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) is indicated for hair removal and permanent hair reduction in all skin types (1-V) to the Fitzpatrick scale. MTONE EVO with 2940 nm Er-Yag Laser Handpiece is indicated for use in soft tissue (skin and cutaneous tissue) such as, but not limited to: skin resurfacing; treatment of wrinkles; epidermal nevi; telangiectasia; spider veins; actinic cheilitis; keloids; verrucae; skin tags; anal tags; keratoses; scar revision (including acne scars). MTONE EVO with 1064 nm Long Pulse (LP) Nd:YAG Laser Handpiece is indicated for: removal of unwanted hair, for stable long-term, or permanent, hair reduction through selective targeting of melanin in hair follicles; removal or lightening of unwanted hair (with and without adjuvant preparation); treatment of pseudofolliculitis barbae (PFB); benign vascular lesions. MTONE EVO with 532/1064 nm Nd:YAG Q-Switch Laser Handpiece is indicated for benign vascular and pigmented lesions, age spots, nevus spilus, and tattoo removal. MTONE EVO with fractional non-ablative 1540 nm Er Glas

Intended Use

MTONE EVO and its Hand Pieces are intended for use in aesthetic, surgical and cosmetic applications and in selective treatments required in the medical specialties of dermatology and general and plastic surgery. MTONE EVO with HR808nm and HR808 XL Laser Handpieces are indicated for the treatment of benign vascular lesions, benign pigmented lesions, hair removal and permanent hair reduction. MTONE EVO with HR760/808/1060nm Laser Hand piece is indicated for benign vascular and vascular dependent lesions removal and temporary hair reduction. MTONE EVO with AC415-950nm Intense Pulsed Light (IPL) Handpiece is indicated for the treatment of inflammatory acne in skin types (1-V) to the Fitzpatrick scale. MTONE EVO with VLPL535-950 nm IPL Handpiece is indicated for the treatment of benign pigmented and vascular lesions in skin types (1-V) to the Fitzpatrick scale. MTONE EVO with VLPL535-950 nm IPL Handpiece with Sub-Millisecond Technology is indicated for the treatment of erythematous rosacea, telangiectasias, port wine stains, benign pigmented lesions and benign vascular lesions. MTONE EVO with HR580-950 nm IPL Handpiece is indicated for hair removal and permanent hair reduction in all skin types (1-V) to the Fitzpatrick scale. MTONE EVO with SR580-950 nm IPL Handpiece is indicated for treatment of benign pigmented epidermal and cutaneous lesions including warts, scars and striae in all skin types (I-VI) to the Fitzpatrick scale. MTONE EVO with HR635-950 nm IPL Handpiece is indicated for hair removal and permanent hair reduction in all skin types (1-V) to the Fitzpatrick scale. MTONE EVO with 2940 nm Er-Yag Laser Handpiece is indicated for use in soft tissue such as skin resurfacing, treatment of wrinkles, epidermal nevi, telangiectasia, spider veins, actinic cheilitis, keloids, verrucae, skin tags, anal tags, keratoses, and scar revision. MTONE EVO with 1064 nm Long Pulse Nd:YAG Laser Handpiece is indicated for removal of unwanted hair, treatment of pseudofolliculitis barbae, and benign vascular lesions. MTONE EVO with 532/1064 nm Nd:YAG Q-Switch Laser Handpiece is indicated for benign vascular and pigmented lesions, age spots, and tattoo removal.

Device Description

MTONE EVO is a multi-functional aesthetic device that utilizes various laser and intense pulsed light (IPL) technologies for a range of cosmetic and medical applications. It includes multiple handpieces designed for specific treatments, such as HR808nm and HR808 XL Laser Handpieces for hair removal and vascular lesions, AC415-950nm IPL Handpiece for acne treatment, and 2940 nm Er-Yag Laser Handpiece for skin resurfacing and soft tissue treatments. The device supports various wavelengths and technologies, including Nd:YAG and IPL, to address different skin types and conditions.

Summary parsed at:2026-06-01 05:27:50 UTC

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