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Temporary hair reduction.
Stable long-term or permanent hair reduction through selective targeting of melanin in hair follicles.
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 on all skin types (Fitzpatrick I-VI) included tanned skin.
Treatment of benign pigmented lesions.
Treatment of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).

Nd: Y AG laser (1064nm):

Removal of unwanted hair for stable long term or permanent hair reatment of PFB. The laser are indicated on all Skin Types Fitzapatrick I-VI including tanned skin.
Photocoagulation and hemostasis of pigmented and vascular lesions, such as but not limited to, port wine stains, hemangioma, warts, teleangiectasia, rosacea, venus lake, leg veins and spider veins.
Coagulation and hemostasis of soft tissue.
Benign pigmented lesions such as, but not limited to, lentigos, (age spots), solar lentigos (such spots), cafe au lait macules, seborrheic keratosis, nevi, cloasma, verrucae, skin tags, keratosis and plaques.
Pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
Treatment of wrinkles.
Temporary increase of clear nail in patients with onychomycosis (e.g.; dermatophytes, Trichophyton rubrumn and T. mentagrophytes, and/or yeast Candida Albicans, etc.)

Device Description

The laser systems (modifications INCANTO, EVOLINE, EVOLINE PLATINUM), provides 1064nm Nd:YAG radiation and 755nm Alexandrite radiation. Availability of two wavelengths (1064nm and 755nm) in one laser system allows to select the most optimal laser radiation exposure type for different skin types.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a Medical Laser System (Incanto / Evoline Platinum / Evoline). This submission aims to prove the substantial equivalence of the new device to existing legally marketed predicate devices.

The acceptance criteria and study proving the device meets these criteria are primarily focused on non-clinical performance testing, specifically related to safety and electromagnetic compatibility, software verification, sterilization, shelf-life, and biocompatibility.

This document does not include information about AI/ML algorithm performance, human reader studies (MRMC), or a detailed clinical effectiveness study with human subjects providing data on therapeutic outcomes. This is a laser device, not an AI/ML-driven diagnostic or therapeutic device that would typically require such studies for a 510(k) submission.

Therefore, I will only be able to answer the relevant sections based on the provided text. Many of the requested points, particularly those related to AI/ML (e.g., sample size for training/test sets, expert adjudication, MRMC studies, standalone algorithm performance, ground truth for AI), are not applicable to this type of medical device submission as detailed in the provided document.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily based on compliance with recognized medical device standards and demonstrated equivalence to predicate devices through technical specifications and non-clinical testing.

1. A table of acceptance criteria and the reported device performance

Category	Acceptance Criteria (Standards/Principles)	Reported Device Performance
I. Safety & Electrical	Compliance with:	"The test results demonstrated that the proposed device complies with the following standards:"
Electrical Safety	IEC 60601-1:+A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance	"Complies with IEC 60601-1:+A1:2012"
EMC (Electromagnetic)	IEC 60601-1-2:2014+AMD1:2020 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance-Collateral Standard: Electromagnetic disturbances - Requirements and tests	"Complies with IEC 60601-1-2:2014+AMD1:2020"
Laser Safety	IEC 60825-1:2014 Safety of Laser products-Part 1: Equipment classification and requirements	"Complies with IEC 60825-1:2014"
Specific Laser Equipment	IEC 60601-2-22:2019 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment	"Complies with IEC 60601-2-22:2019"
II. Software	Software verification and validation testing conducted as recommended by FDA's "Content of Premarket Submissions for Device Software Functions" guidance.	"Software verification and validation testing were conducted, and documentation was provided as recommended by FDA’s Content of Premarket Submissions for Device Software Functions, 'Guidance for Industry and Food and Drug Administration Staff.'" Software deemed "Basic Documentation" level of concern.
III. Biocompatibility	Compliance with ISO 10993-1 for device components in contact with intact skin (Cytotoxicity, Sensitization, Irritation).	"Three biological effects, cytotoxicity, sensitization and irritation testing, were performed and test results did not identify any biological response or risk. The Medical Laser System Incanto / Evoline Platinum / Evoline meets the ISO 10993-1 standard requirements for biocompatibility and no further characterization testing is required."
IV. Other Performance	Laser energy output verification.	"The Medical Laser System Incanto / Evoline Platinum / Evoline has been determined through engineering testing to verify laser energy output..."
Sterilization/Shelf-Life	Device is not provided sterile and does not have a restricted shelf-life; reusability is supported. (The criteria here would be that it functions as a reusable device and does not require sterilization, supported by cleaning instructions.)	"The proposed device is not provided sterile and does not need to be sterilized. The handpiece and the body are cleaned with a soft cloth moistened with ethanol of 70% strength or higher. The proposed device is reusable and does not have a restricted shelf-life."
Substantial Equivalence	The proposed device shares similar indications for use, design features, technological characteristics, and principles of operation as its predicate devices, with minor differences not raising new questions of safety or effectiveness.	"The Medical Laser System Incanto / Evoline Platinum / Evoline shares similar indication of use, the same design feature, the similar technological characteristics, and the same principles of operation as its predicate devices. The minor differences between the proposed device and the predicate devices have been conducted related non-clinical tests as part of the design validation to identify that they are not sufficient to raise new questions of safety. Based on above analysis, the Medical Laser System Incanto / Evoline Platinum / Evoline is as safe, as effective, and performs as well as the cited predicate devices K233090 and K122493."

Non-Applicable Sections (Related to AI/ML Performance Studies)

As stated previously, the provided document is for a traditional laser medical device, not an AI/ML algorithm. Therefore, the following sections are not applicable and no information is available in the text to address them:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. This submission details non-clinical engineering and biological safety testing, not a clinical performance study with human data.

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)

Not Applicable. No ground truth established by experts for a test set is mentioned, as this is not an AI/ML diagnostic or prognostic device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. No test set requiring adjudication is mentioned.

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

Not Applicable. No MRMC study was performed or is relevant for this device type.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is a hardware device; the concept of "standalone algorithm only" does not apply.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable. Ground truth, in the context described (e.g., for diagnostic accuracy), is not relevant for this engineering and safety-focused submission. The "ground truth" for the tests performed is established by the validated methods of the referenced IEC and ISO standards.

8. The sample size for the training set

Not Applicable. No training set for an AI/ML algorithm is mentioned.

9. How the ground truth for the training set was established

Not Applicable. No training set for an AI/ML algorithm is mentioned.

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