MT ONE

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

Predicate devices

2

Cited as predicate

2

Device details

FDA 510(k) registration fields

K number
K172413
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
2017-08-10
Decision date
2017-10-06
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 of dermatology and general and plastic surgery.

MT ONE with HR808USnm Laser Handpiece is indicated for treatment of benign vascular lesions, benign pigmented lesions, hair removal and permanent hair reduction.

MT ONE with AC415-950USnm 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 VLPL535-950USnm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) is indicated for the treatment of Benign Pigmented and Vascular Lesions in all skin types (I-VI) to the Fitzpatrick Scale.

MMT ONE with HR580-950USnm 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.

MMT ONE with SR580-950USnm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) is indicated for the treatment of Benign Pigmented Epidermal and Cutaneous Lesions including warts, scars and striae in all skin types (I-VI) to the Fitzpatrick Scale.

MMT ONE with HR635-950USnm 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 Er-Yag2940USnm 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 Nd:YAG1064(LP)USnm 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 or without adjuvant preparation);
- Treatment of pseudofolliculitis barbae (PEB).

*Permanent hair reduction is defined as the long term, stable reductions in the number of hairs when measured at 6, 9 and 12 months after the completion of a treatment regime.

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 of dermatology and general and plastic surgery. MT ONE with HR808USnm Laser Handpiece is indicated for treatment of benign vascular lesions, benign pigmented lesions, hair removal and permanent hair reduction*. MT ONE with AC415-950USnm 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 VLPL535-950USnm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) is indicated for the treatment of Benign Pigmented and Vascular Lesions in all skin types (I-VI) to the Fitzpatrick Scale. MT ONE with HR580-950USnm 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 SR580-950USnm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) is indicated for the 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 HR635-950USnm 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 Er-Yag2940USnm 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 Nd:YAG1064(LP)USnm 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 or without adjuvant preparation); Treatment of pseudofolliculitis barbae (PEB). *Permanent hair reduction is defined as the long term, stable reductions in the number of hairs when measured at 6, 9 and 12 months after the completion of a treatment regime.

Device Description

MT ONE is an Intense Pulsed Light (IPL) and laser emitting device that is operated with handpiece in contact with the skin. MT ONE comprises a main console unit and several handpieces that are triggered by means of footswitch or a finger switch. A microprocessor based system controller is used to monitor and direct all the system function and the graphic user interface. The main console can be connected to the following handpieces: HR808USnm Laser diode; AC415-950USnm intense Pulsed Light; VLPL535-950USnm Intense Pulsed Light; HR580-950USnm Intense Pulsed Light; SR580-950USnm Intense Pulsed Light; HR635-950USnm Intense Pulsed Light; Er-Yag Laser 2940 nm; Nd:Yag LP Laser 1064 nm.

Summary parsed at:2026-06-01 06:00:47 UTC

Predicate devices

2

K172413 references 2 predicate/reference devices

Cited as predicate

2

2 submissions cite K172413 as a predicate