Manufacturer
M&T S.R.L.MT One
Country / Region:Italy (IT)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K192856
- Device name
- MT One
- 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
- 2019-10-04
- Decision date
- 2020-04-24
- Submission type
- Traditional
- Technology type
- Diode(AI inferred)
- Clinical applications
- Hair removalPigment treatmentVascular treatment
- Primary application
- Hair removal
- Classification source
- AI classified
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 lesions (eg Diffuse Redness). MT ONE 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 (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 for 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. 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
Intended 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 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 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 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 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 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 is indicated for 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. 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 1
Device Description
MT ONE has the same technological characteristics (energy source, laser/IPL source, control mechanisms) and specifications as its predecessors.
Summary parsed at:2026-06-01 05:47:07 UTC
Predicate devices
7—
—
Not ingested
—
—
Not ingested
Lumenis M22 System
Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra
Quanta Forte
Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra
MT ONE
K192856 references 7 predicate/reference devices
Cited as predicate
2Platform treatment system
Multi-function Platform Systems (BL-M10)
2 submissions cite K192856 as a predicate
