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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. 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, anal tags, keratoses, scar revision (including acne scars), debulking benign tumors, debulking cysts and superficial skin lesions.

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

The 1440 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, furrows, fine lines, textural irregularities, dyschromia 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 circulation 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 treatments; 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 Skintel™ Reader is intended as an objective measurement tool for examining skin melanin content for determining and setting a test spot starting fluence.

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 510(k) submission (K110907) is for the Palomar Icon™ Aesthetic System, a light and laser system intended for various dermatological and surgical applications. The submission primarily focuses on establishing substantial equivalence to previously cleared predicate devices rather than providing detailed performance studies with acceptance criteria for a new AI/software device.

Therefore, most of the requested information cannot be extracted directly from this document. The document states:
"The review of the technical characteristics. indications for use, clinical data, verification and validation information provided in the 510(k) Premarket Notification demonstrates that the Palomar Icon Aesthetic System is substantially equivalent to its predicate i device." and "The Palomar Icon Aesthetic System is substantially equivalent to its predicate devices when used according to its intended use. This is based on the information provided in this 510(k) Premarket Notification which demonstrates that the Palomar Icon Aesthetic System shares the same technological characteristics, mechanism of action, intended use and physical properties when compared to its predicates."

This indicates that the focus was on demonstrating similar technological characteristics and intended use to existing devices, rather than presenting new performance data against specific acceptance criteria for a novel AI or software component.

However, I can extract information related to the Skintel™ Reader, which is a component of the system and has a specific function:

Skintel™ Reader Information:

• Intended Use: "The Skintel™ Reader is intended as an objective measurement tool for examining skin melanin content for determining and setting a test spot starting fluence."

Based on the provided text, the following information cannot be determined:

• A table of acceptance criteria and reported device performance (for the overall system or the Skintel™ reader, as this is a substantial equivalence submission)
• Sample size used for the test set
• Data provenance
• Number of experts used to establish ground truth
• Qualifications of experts
• Adjudication method
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done
• Effect size of human readers improvement with AI vs without AI assistance
• If a standalone (algorithm only) performance study was done
• The type of ground truth used
• The sample size for the training set
• How the ground truth for the training set was established

Missing Information/Why it cannot be provided from the text:

The provided 510(k) summary is a high-level overview focused on demonstrating substantial equivalence to predicate devices, as is typical for many medical device clearances. It does not contain the detailed performance study results, acceptance criteria, or methodological specifics that would be required for an AI/software device. For instance, the "Performance Data" section simply states that the review "demonstrates that the Palomar Icon Aesthetic System is substantially equivalent," without providing specific metrics or criteria.

To answer the requested questions comprehensively for a device like the Skintel™ Reader (an "objective measurement tool"), one would typically need a much more detailed technical report or clinical study report, which is not part of this 510(k) summary. This report would describe validation studies showing the accuracy and precision of the melanin content measurement, comparison to a gold standard, and how these measurements correlate with "setting a test spot starting fluence."

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