(200 days)
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, hair 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: frequency = 9 Hz)
MTONE EVO with AC415-950nm Intense Pulsed Light (IPL) Handpiece (with and without contactcooling) is indicated for the treatment of Inflammatory Acne vulgaris) in skin types (I-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 (I-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 Piqmented Lesions (eq Mottled Pigmentation, Ephilides) and Benign Vascular lesion(eq Diffuse Redness).
MTONE EVO with HR580-950 nm Intense Pulsed Light (IPL) Handpiece (with and without contactcooling) is indicated for the hair removal and permanent hair reduction* in all skin types (I-V) to the Fitzpatrick scale.
MTONE EVO with SR580-950 nm Intense Pulsed Light (IPL) Handpiece (with and without contactcooling) 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 Light (IPL) Handpiece (with and without contactcooling) is indicated for hair removal and permanent hair reduction* in all skin types (I-V) to the Fitzpatrick scale.
MTONE EVO with HR635-950 nm Intense Pulsed Light (IPL) Handpiece (with and without contactcooling) In-Moving is indicated to Hair removal and permanent Hair reduction in all skin types (I-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; 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
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, hair 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: frequency = 9 Hz)
MTONE EVO with AC415-950nm Intense Pulsed Light (IPL) Handpiece (with and without contactcooling) is indicated for the treatment of Inflammatory Acne vulgaris) in skin types (I-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 (I-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 Piqmented Lesions (eq Mottled Pigmentation, Ephilides) and Benign Vascular lesion(eq Diffuse Redness).
MTONE EVO with HR580-950 nm Intense Pulsed Light (IPL) Handpiece (with and without contactcooling) is indicated for the hair removal and permanent hair reduction* in all skin types (I-V) to the Fitzpatrick scale.
MTONE EVO with SR580-950 nm Intense Pulsed Light (IPL) Handpiece (with and without contactcooling) 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 Light (IPL) Handpiece (with and without contactcooling) is indicated for hair removal and permanent hair reduction* in all skin types (I-V) to the Fitzpatrick scale.
MTONE EVO with HR635-950 nm Intense Pulsed Light (IPL) Handpiece (with and without contactcooling) In-Moving is indicated to Hair removal and permanent Hair reduction in all skin types (I-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; 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
This document is a 510(k) clearance letter from the FDA for the MTONE EVO device. It states that the device is substantially equivalent to legally marketed predicate devices and lists its various indications for use. However, it does not contain the information requested about acceptance criteria, device performance, study design (sample size, data provenance, expert
ground truth, adjudication, MRMC, standalone performance), or training set details.
Therefore, I cannot fulfill your request using the provided text. The document is strictly a regulatory clearance and does not include the technical study details you are asking for.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.