# K240604: Mtone Evo (Mtone Evo)

- Pathway: 510(k) (Traditional)
- Applicant: M&T S.R.L.
- Decided: Sep 20, 2024 after 200 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## 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, lhair removal and permanent hair reduction*. MTONE EVO with HR760/808/1060nm Laser Handpiece is indicated for Benign vascular and vascular dependent lesions removal (VL mode: freqiuency < 9 Hz) and temporary hair reduction (HR In-moving mode: frequency > = 9 Hz) MTONE EVO with AC415-950nm Intense Pulsed Li\1ht (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 erythematous rosacea, Telangiectasias, PWS (Port Wine Stains) Benign Pigmented Lesions (eg Mottled Pigmentation, Ephilides) and Benign Vascular lesion(eg Diffuse Redness). MTONE EVO with HR580-950 nm Intense Pulsed Liight (IPL) Handpiece (with and without contact-cooling) is indicated for the hair removal and permanent hair reduction* in all skin types (1-V) to the Fitzpatrick scale. MTONE EVO with SR580-950 nm Intense Pulsed Liight (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 Liight (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 HR635-950 nm Intense Pulsed Liight (IPL) Handpiece (with and without contact-cooling) In-Moving is indicated to 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 chelitis; 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. * 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 regime. MTONE EVO with 532/1064 nm Nd:YAG Q-Switch Laser Handpiece is indicated for: «» Benign vascular and pigmented lesions, age spots * Nevus spilus » Tattoo removal MTONE EVO with fractional non-ablative 1540 nm Er Glass Laser Handpiece is indicated for » Post-operative Scars, Acne Scars, Skin Resurfacing, Striae

Source page: https://510kreport.com/device/K240604
Methodology: https://510kreport.com/methodology