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Nd:YAG Laser (1064 nm): removal of unwanted hair, for stable long term or permanent hair reduction (Skin Types Fitzpatrick I-VI), photocoagulation and hemostasis of pigmented and vascular lesions, such as but not limited to warts, teleangiectasia, leg veins and spider veins, treatment of benign pigmented lesions.

Er:YAG Laser attachment (2940 nm): skin resurfacing and incision, excision, ablation or vaporization of soft bodily tissues.

Q-switched Nd:YAG Laser attachment (1064 nm): removal of dark tattoos and treatment of benign pigmented lesions.

Pulsed Light attachments (400, 500, 520, 550, 650 to 950 nm): permanent hair reduction, treatment of benign cutaneous vascular lesions including facial and leg veins, benign pigmented epidermal lesions, moderate inflammatory acne vulgaris.

Different wavelength ranges of Pulsed Light attachments are indicated for the various treatments and skin types, as indicated in the following table:

| Pulsed Light
wavelength range | Moderate
Inflammatory Acne
Vulgaris | Benign Cutaneous
Vascular Lesions | Benign Pigmented
Epidermal Lesions | Permanent Hair
Reduction |
|----------------------------------|-------------------------------------------|--------------------------------------|---------------------------------------|-----------------------------|
| 400 - 950 nm | Skin Types I, II, III, IV | --- | --- | --- |
| 500 - 950 nm | --- | Skin Types I, II | --- | --- |
| 520 – 950 nm | --- | Skin Type III | Skin Types I, II | Skin Types I, II |
| 550 - 950 nm | --- | --- | Skin Types III, IV | Skin Types I, II, III |
| 650 - 950 nm | --- | --- | --- | Skin Type IV |

The Synchro HP Platform laser and pulsed light system is equipped with a long pulse Nd: YAG laser (1064 nm), several hand held pulsed light sources (400-950 nm), a hand-held Er: Y AG laser source (2940 nm) and a hand-held Q-switched Nd: Y AG laser source (1064 nm). Emission activation is either by footswitch or finger switch. Overall weight of the system is 170 kg. Size is 115x53x106 cm (HxWxD). Electrical requirement is: 230VAC, 32A, 50-60 Hz, single phase.

The provided document, K082039, is a 510(k) Pre-market Notification for the Synchro HP Platform. This submission aims to demonstrate that the device is substantially equivalent to legally marketed predicate devices.

Critical finding from the document: The K082039 submission states "None" for both "Nonclinical Performance Data" and "Clinical Performance Data". This indicates that no specific acceptance criteria or studies proving device performance were presented in this 510(k) summary.

Therefore, the following information is not available from the provided text, as no performance study was submitted for this 510(k).

1. A table of acceptance criteria and the reported device performance
Information not available, as no performance studies or acceptance criteria are presented in the 510(k) summary.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Information not available, as no performance studies were submitted.

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)
Information not available, as no performance studies were submitted.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Information not available, as no performance studies were submitted.

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
Information not available. This device is a laser and pulsed light system, not an AI-assisted diagnostic tool, so an MRMC study comparing human readers with and without AI would not be applicable in this context. Furthermore, no clinical studies were submitted.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Information not available. This device is a laser and pulsed light system, not an algorithm. Furthermore, no performance studies were submitted.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Information not available, as no performance studies were submitted.

8. The sample size for the training set
Information not available, as no performance studies were submitted.

9. How the ground truth for the training set was established
Information not available, as no performance studies were submitted.

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