# K192856: MT One - Pathway: 510(k) (Traditional) - Applicant: M&T S.R.L. - Decided: Apr 24, 2020 after 203 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 Longest line of descent: 23 generations back to K943450 (1995). 574 ancestors in all. 2 later devices descend from it; 2 cite it directly. 0 of 577 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K110907: Palomar Icon (TM) Aesthetic System, Palomar Medical Technologies, Inc. (2011) Summary page 5. - K152714: Quanta Forte, Quanta System Spa (2015) Summary page 5. - K111303: Dermatological Treatment Device Family, Sharplight Technologies, Ltd. (2011) Summary page 5. - K072564: Alma Lasers Harmony XL Multi-Application Platform, Alma Lasers, Ltd. (2008) - K142860: Lumenis M22 System, Lumenis, Ltd. (2015) Summary page 5. - K172413: MT ONE, M&T S.R.L. (2017) Summary page 5. - K150907: Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra, Ellipse A/S (2015) Summary page 5. - K161162: Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra, Ellipse A/S (2016) Summary page 5. ## Most influential descendants - K203395: Platform treatment system (2022), 1 descendant of its own - K240474: Multi-function Platform Systems (BL-M10) (2024), 0 descendants of its own ## Indications for use MT ONE 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. MT ONE with HR808nm Laser Handpiece is indicated for the treatment of benign vascular lesions, benign pigmented lesions, hair removal and permanent hair reduction*. MT ONE 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 (I-V) to the Fitzpatrick scale. MT ONE 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 (I-V) to the Fitzpatrick scale. MT ONE 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 (eg Mottled Pigmentation, Ephilides) and Benign Vascular lesion(eg Diffuse Redness). MT ONE with HR580-950 nm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) is indicated for the hair removal and permanent hair reduction* in all skin types (I-VI) to the Fitzpatrick scale. MT ONE 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. MT ONE 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 (I-VI) to the Fitzpatrick scale. MT ONE with HR635-950 nm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) In-Moving is indicated Hair removal and permanent Hair reduction in all skin types (I-VI) to the Fitzpatrick scale MT ONE 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). MT ONE 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. MT ONE with 532/1064 nm Nd:YAG Q-Switch Laser Handpiece is indicated for: • Benign vascular and pigmented lesions, age spots • Nevus spilus • Tattoo removal MT ONE 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/K192856 Methodology: https://510kreport.com/methodology