(203 days)
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: Y AG 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
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.
The main console of MT ONE is the same, with no modification, of the predicated devices cleared by K172413. The difference is only in the addition of 4 new handpieces, see list below.
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:
Handpieces that are already cleared by K172413
- -HR808 nm laser diode
- -AC415-950 nm Intense Pulsed Light
- -VPLP535-950 nm Intense Pulsed Light
- -SR580-950 nm Intense Pulsed Light
- -HR580-950 nm Intense Pulsed Light
- -HR635-950 nm Intense Pulsed Light
- -2940 nm ERBIUM YAG laser
- -1064 nm ND:YAGLP laser
Handpieces object of this submission:
- 532/1064 nm ND:YAG Q-Switched laser -
- -Fractional non-ablative 1540 nm Er:Glass laser
- -VPLP535-950 nm Intense Pulsed Light with S.M.T.
- -HR635-950 nm Intense Pulsed Light In Moving
The provided text is a 510(k) summary for the MT ONE device. It details various aspects of the device, its intended uses, and comparisons to predicate devices. However, it does not contain specific acceptance criteria, performance metrics, or study designs that would typically be found in a clinical study report. The "Performance data" section only mentions biocompatibility testing, electrical safety/EMC, and software verification/validation, which are engineering and regulatory compliance tests, not clinical performance studies.
Therefore, many of the requested details about acceptance criteria and clinical study performance cannot be extracted from this document. The document focuses on establishing substantial equivalence based on technological characteristics and safety standards rather than clinical efficacy studies with ground truth.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided: The document does not specify quantitative acceptance criteria for clinical performance (e.g., sensitivity, specificity, accuracy, or specific levels of treatment success) or report device performance against such criteria. The performance data section focuses on engineering and regulatory compliance (biocompatibility, electrical safety, software V&V) rather than clinical outcomes.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Cannot be provided: The document does not describe any clinical test set or study participants. The testing mentioned is related to engineering and software, not clinical trials.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Cannot be provided: No clinical test set or ground truth establishment process is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Cannot be provided: No clinical test set or adjudication method is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Cannot be provided: This document describes a laser and IPL device for various skin treatments, not an AI-assisted diagnostic device. Therefore, an MRMC study or AI assistance is not applicable and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided: As mentioned above, this is not an AI algorithm but a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Cannot be provided: No clinical ground truth is described in the context of the performance data provided. The document outlines comparisons of technical specifications and intended uses to predicate devices to establish substantial equivalence.
8. The sample size for the training set
- Cannot be provided: The document does not describe any machine learning or AI components that would require a training set.
9. How the ground truth for the training set was established
- Cannot be provided: Not applicable, as there is no mention of a training set for an AI/ML model.
§ 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.