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

7

Cited as predicate

2

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

K192856 references 7 predicate/reference devices

Cited as predicate

2

2 submissions cite K192856 as a predicate