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The 2940 Ablative Laser Handpiece is intended for use in surgical applications requiring the excision, incision, ablation, vaporization, and coagulation of soft tissue includes skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, calculi or fragments, mucous membrane, lymph vessels and nodes, organs, and glands in the following indications: skin resurfacing, treatment of wrinkles, epidermal nevi, telangiectasia, spider veins, actinic chelitis, keloids, verrucae, skin tags, keratoses, scar revision (including acne scars), debulking benign tumors, debulking cysts and superficial skin lesions.

The 2940 Ablative Laser Fractional Handpiece is intended for use in dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, rhytides, fine lines, textural irregularities, pigmented lesions, and vascular dyschromia.

The 1540 Fractional Non-ablative Laser Handpiece is intended for use in coagulation of soft tissue, skin resurfacing procedures as well as treatment of melasma, striae, acne scars and surgical scars.

The 1440 Fractional Non-ablative Laser Handpiece is intended for use in dermatological procedures requiring coagulation of soft tissue and skin resurfacing procedures.

The 1540 and 2940 Fractional combined treatment is intended for dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, rhytides, fine lines, textural irregularities, dyschromia and pigmented lesions.

he 1440 and 2940 Fractional combined treatment is intended for dermatological procedures quiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin surfacing and treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, schromia and pigmented lesions.

The IR Handpiece is intended for photocoagulation of soft tissue in dermatologic applications. In addition, it is intended to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local culation where applied, and the relaxation of muscles. In addition, it may also help muscle spasms, minor sprains and strains, and minor muscular back pain.

The 1064 Laser Handpiece is intended for the removal of unwanted hair for skin types I-VI, and to effect stable long-term permanent hair reduction; treatment of benign pigmented lesions such as, but not limited to, senile lentigines (age spots), solar lentigos (sun spots), pigmented seborrheic keratoses, nevi, chloasma, cafe-au-lait macules, and plaques; verrucae, skin tags, seborrheic keratosis; tattoos (significant reduction in the intensity of black and/or blue-black tattoos); 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/light treatment of vascular lesions such as but not limited to, port wine stains, hemangiomas, telangiectasias, rosacea, venus lake, facial and leg veins; reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar; coagulation and hemostasis of soft tissue; treatment of wrinkles and pseudofolliculitis barbae (PFB).

The Max Series Intense Pulsed Light Handpieces are intended for the treatment of inflammatory acne (acne vulgaris) and for the treatment of benign pigmented epidermal and cutaneous lesions, including warts, scars and striae; removal of unwanted hair from skin types I-VI, and to effect stable long-term, or permanent, hair reduction; treatment of benign pigmented lesions, including lentigines, nevi, melasma, and cafe-au-lait; and treatment of vascular lesions, including port wine stains, hemangiomas, angiomas, telangiectasias, rosacea, facial and leg veins.

The Palomar Icon Aesthetic System consists of a console with an internal power supply, chiller, and electronics. The light and laser handpieces individually connect to the system via the console connection port.

This document is a 510(k) summary for the Palomar Icon™ Aesthetic System, indicating substantial equivalence to predicate devices. It does not contain acceptance criteria for specific performance metrics or detailed study results proving the device meets such criteria. Instead, it relies on the assertion of "substantial equivalence" to previously cleared devices.

Therefore, most of the requested information cannot be extracted from this document, as it outlines the regulatory submission, intended uses, and device description, rather than clinical performance data against pre-defined acceptance criteria.

Here's an attempt to answer what can be gathered, with clear indications where information is not available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not available in this document. The submission relies on "performance data" but does not detail studies with specific sample sizes for a 'test set'.
• Data Provenance: Not available in this document. The document mainly discusses regulatory equivalence and does not specify the country of origin of any data, nor whether it was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

• Number of Experts: Not applicable/Not available. This document does not describe the establishment of ground truth by experts for a test set, as no specific clinical performance study is detailed against newly established ground truth.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/Not available. No specific test set performance study or adjudication process is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study Done: No, based on the information provided. The document does not describe any MRMC study or the effect size of human readers with vs. without AI assistance. The device is a laser/light system, not an AI diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

• Standalone Performance Study Done: Not applicable/Not available. This device is a physical system (laser/light handpieces) for aesthetic and surgical procedures, not an algorithm. Therefore, "standalone algorithm performance" is not relevant in this context.

7. Type of Ground Truth Used

• Type of Ground Truth: Not applicable/Not available in the context of a performance study against specific ground truth. The submission relies on the concept of "substantial equivalence" to predicate devices, meaning its safety and effectiveness are deemed similar to devices already on the market and legally used. No new ground truth establishment is described for proving efficacy of the Icon system itself as a novel device.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable/Not available. This document pertains to a physical medical device, not an AI/ML algorithm that would typically involve a "training set."

9. How the Ground Truth for the Training Set Was Established

• How Ground Truth for Training Set Was Established: Not applicable/Not available. As above, this document does not describe an AI/ML algorithm that uses a training set with established ground truth.

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