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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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The Cutera Optional Pulsed Light Hand Piece Family is indicated for use in the surgical, aesthetic and cosmetic applications requiring selective photothermolysis in the medical specialties of general and plastic surgery and dermatology.

The Cutera Optional Pulsed Light Hand Piece Family is intended for the treatment of:

• Tattoos;
• Benign pigmented lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles);
• Cutaneous lesions including warts, scars and striae;
• Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, roasacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations;
• Psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis;
• Removal of unwanted hair from all skin types, and to effect stable long-term, or permanent, hair reduction; and
• Mild to moderate inflammatory acne vulgaris.

The pulsed light delivery hand pieces are comprised of four main components:

• an "umbilica!" cable and connector, that is permanently attached to the hand piece body and is semi-permanently attached to the console system (detachable by positive action from the user) that houses:
• electrical cables (to support the thermoelectric cooler associated with the chilled hand piece tip, to provide power and a trigger source to the xenon flash lamp, to provide detector signals and to connect a memory device that identifies the hand piece);
• a supply and return water line (to remove the heat generated by the flash lamp and thermoelectric cooler);
• the hand piece internals described above; and
• the hand piece housing the internals and connecting to the umbilical.

These hand pieces are accessories to be used on previously cleared Cutera console systems where the 510(k) permitted use of pulsed light (a.k.a. flash lamp) hand pieces.

The provided text is a 510(k) summary for the Cutera Optional Pulsed Light Hand Piece Family. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain any information about a clinical study with acceptance criteria and reported device performance data.

The document states: "The new indications for use are based upon the indications for use for predicate pulsed light device systems. Technologically, the Cutera Optional Pulsed Light Hand Piece Family is substantially equivalent to the listed predicate devices. Therefore the risks and benefits for the Cutera Optional Pulsed Light Hand Piece Family are comparable to the predicate devices. We therefore believe that there are no new questions of safety or effectiveness raised by the introduction of this device."

This explicitly indicates that the submission relies on the established safety and effectiveness of the predicate devices and does not present new study data to demonstrate compliance with specific acceptance criteria for the new device.

Therefore, I cannot fulfill your request for points 1-9 as the necessary information is not present in the provided text.

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The Aurora DS is indicated for the removal of unwanted hair from skin types I-VI, and to effect stable long-term, or permanent, hair reduction.

The Aurora DS is a device indicated for the removal of unwanted hair from skin types I-VI, and to effect stable longterm, or permanent, hair reduction. The Aurora DS treatment is based on the principle of selective (electromagnetic) thermolysis. According to this principle, parameters of optical and RF energy (spectrum, exposure duration and energy density) are chosen and optimized to selectively damage to the hair follicle without damaging the surrounding tissues.

This 510(k) summary does not contain the detailed information necessary to complete all sections of your request, particularly regarding specific acceptance criteria values, sample sizes, and expert qualifications for performance studies.

This is common for older 510(k) submissions, which often presented less granular data than more recent ones require. Instead, it focuses on demonstrating substantial equivalence to predicate devices.

However, I will extract and infer information where possible based on the provided text.

Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for hair removal or reduction beyond indicating the device should "effect stable long-term, or permanent, hair reduction." It relies on substantial equivalence to predicate devices, implying that its performance is expected to be comparable.

Study Details

Given the context of a 510(k) submission primarily focused on substantial equivalence to predicate devices, detailed clinical study methodologies are not provided in this summary. The summary highlights that "Based upon an analysis of the overall performance characteristic for the device, Syneron Medical Ltd. believes that no significant differences present." This general statement suggests that any studies conducted were likely aimed at demonstrating this equivalence rather than establishing de novo performance metrics against specific criteria.

1. Sample Size used for the test set and the data provenance:
   • Sample Size: Not specified in the provided summary.
   • Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   • Not specified.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   • Not specified.
4. 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. This device is a hair removal system, not an AI-assisted diagnostic tool.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
   • Not applicable as this is a device for hair removal, not an algorithm. Performance is inherent to the device's design and mechanism.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   • Not explicitly stated. For hair removal devices, ground truth for efficacy would typically involve quantitative hair counts or subjective photographic assessments by clinicians and/or patients over time.
7. The sample size for the training set:
   • Not applicable, as this is a medical device for hair removal, not an AI/machine learning algorithm with a training set.
8. How the ground truth for the training set was established:
   • Not applicable.

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NaturaLight IPL System (intense pulsed light) is indicated for: The removal of unwanted hair from skin types I-VI, and to effect stable long-term, or permanent, hair reduction. The treatment of benign pigmented lesions, including lentigines, nevi, melasma, and cafe-au-lait. treatment of vascular lesions, including port wine stains, hemangiomas, telangiectasias, rosacea, facial and leg veins.

The Focus Medical NaturaLase LP Laser System and the NaturaLase LP+ System when used in Laser Mode is indicated for: General Surgical Applications: Incision, excision, coagulation, hemostasis, vaporization, and/or ablation of soft tissue dermatology/plastic surgery, endoscopic/laparoscopic general surgerv. in gastroenterology, general surgery, gynecology, head and neck/ otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonary surgery, thoracic surgery, and urology.

Dermatology/Plastic Surgery: Coagulation and hemostasis of benign vascular lesions such as port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg and spider veins. In addition, the NaturaLase LP is intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques. The NaturaLase LP Laser is also indicated for 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. Cutting, incision, excision, hemostasis, coagulation, vaporization and ablation of soft tissue in dermatology and plastic surgery. The NaturaLase LP Laser is also indicated for the treatment of facial wrinkles and wrinkles such as, but not limited to, periocular and periorbital wrinkles. The NaturaLase LP Laser is indicated for the removal of unwanted hair, for the stable long tem, or permanent, hair reduction through selective targeting of melanin in hair follicles, and for the treatment for pseudofolliculitis barbae (PFB). The NaturaLase LP Laser is indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. The NaturaLase LP Laser is indicated for use on all skin types (Fitzpatrick I - VI) including tanned skin.

Endoscopic/Laparoscopic Surgery: The Natural.ase LP Laser is also indicated for use in a variety of surgical procedures in several surgical specialties. These include, but not limited to, cholecystectomy, appendectomy, vagotomy, and pyloromyomotomy where its abilities to incise, excise, coagulate, vaporize, or ablate soft tissue may be applied.

Gastroenterology: Tissue ablation and hemostasis in the gastrointestinal tract; esophageal neoplastic obstruction including squamous cell carcinoma and adenocarcinoma, gastrointestinal hemostasis including varices, esophageal ulcer, Mallory-Weiss tear, gastric ulcer, angiodysplasia, stomal ulcers, non-bleeding ulcers, gastric erosions, gastrointestinal tissue ablation including benign and malignant neoplasm, angiodysplasia, polyps, ulcer, colitis, and hemorrhoids.

General Surgery: Incision, excision, vaporization, ablation, and hemostasis of soft tissue general surgery applications, skin incisions, tissue dissection, excision of external turnors and lesions, complete or partial resection of internal organs, tumors, lesions, tissue ablation, vessel coagulation, tonsillectomy, and hemorrhoids.

Gynecology: Treatment of menorhagia by photocoagulation of the endometrial lining of the uterus. ablation of endometrial implants and/or peritoneal adhesions, soft tissue excisional procedures such as excisional conization of the cervix, intrauterine gynecologic procedures where cutting, ablation, and/or vessel coagulation may be indicated including submucous fibroids, benign endometrial polyps, and uterine septum.

Head and Neck/Otorhinolaryngology (ENT): Tissue incision, excision, ablation, and vessel hemostasis.

Hemostasis During Surgery: Adjunctive coagulation and hemostasis (bleeding control) during surgery in endoscopic (e.g. laparoscopic) and open procedures.

Neurosurgery: Hemostasis for pituitary tumor, meningioma, hemagioblastoma, AVMs. glioblastoma, astrocytoma, oligodendroglioma.

Oculoplastics: Incision, excision, vaporization, and/or coagulation of tissues in oculoplastic procedures such as operations on the lacrimal system, operation on the eyelids, removal of biopsv or orbital tumors, enucleation on eyeball, exteneration of orbital contents.

Orthopedics: Cutting, ablation, and/or hemostasis of intra-articular tissue in orthopedic surgical and arthroscopic applications.

Pulmonary Surgery: Palliative treatment of benign and malignant pulmonary airway obstructions, including squamous cell carcinoma, adenocarcinoma, carcinoid, benign tumors, granilo mas, and benign strictures.

Thoracic Surgery: Cutting (incision/excision), coagulating, and vaporization of soft tissue. Thoracic applications including, but not limited to, isolation of vessels for endarterectomy and/or by-pass grafts, wedge resections, thoractomy, formation of pacemaker pockets, vaporization, coagulation, incision/excision, debulking, and ablation of lung tissue (thoracoscopy).

Urology: All applications including superficial urinary bladder tumors, invasive bladder carcinoma, urethral strictures and lesions of the external genitalia (including condyloma acuminata).

The Focus Medical NaturaLase LP and NaturaLight Family of Products consists of the NaturaLase LP Nd: YAG Laser System, the NaturaLight IPL System and the NaturaLase LP+ a simple combination of the NaturaLase LP and the NaturaLight.

This document is a 510(k) premarket notification for a medical device submitted to the FDA in 2004. It outlines the device's summary and indications for use, but does not contain information regarding acceptance criteria or a study proving the device meets said criteria.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence to predicate devices, not on performance studies with specific acceptance criteria.

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