(29 days)
The 2940 Ablative Laser Handpiece is intended for use in surgical applications requiring the excision, incision, vaporization, and coagulation of soft tissue. Soft tissue includes skin, cutaneous 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 the 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 Fractional Non-ablative Laser and 2940 Fractional Abaltive Laser Handpiece combined treatment is intended for dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrides, furrows, fine lines, textural irregularities, dyschromia and pigmend lesions.
The 1440 Fractional Non-ablative Laser Handpiece and 2940 Fractional Ablative Laser Handpiece 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 irregularties, dyschromia and pigmented lesions.
The MaxIR 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 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 seratosis; 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 (FFB).
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 port wine stains, hemangiomas, aniomas, 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 including attachable treatment handpieces is designed to deliver pulses of broadband incoherent or laser light to a predetermined target site. The Palomar Icon® Aesthetic System consists of three stacking modules that contain an internal power supply, control electronics, Chiller Module, Heat Exchanger Module, Base Module, remote interlock, emergency-off button, footswitch, power control, and front panel monitor with indicators. They system includes multiple treatment hadnpieces attached to the Base Module. Each Handpiece provides laser energy at a specific wavelength or Intense Pulsed Light (IPL) at a specific range.
The provided text is a 510(k) summary for the Palomar Icon Aesthetic System, a medical device. It describes the device, its intended use, and a comparison to a legally marketed predicate device. However, it does not include detailed acceptance criteria or a study proving the device meets specific performance criteria in terms of clinical outcomes or diagnostic accuracy.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (Palomar Icon Aesthetic System, K110907) based on technological characteristics and non-clinical tests (sterilization validation). Clinical performance studies with defined acceptance criteria and statistical analysis are not detailed in this submission.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance: The document does not specify quantitative acceptance criteria for clinical performance (e.g., specific percentages of wrinkle reduction, hair removal efficacy, or lesion clearance) or report device performance against such criteria.
- Sample size and data provenance for the test set: No clinical test set is described.
- Number and qualifications of experts for ground truth: No ground truth establishment related to clinical outcomes is mentioned.
- Adjudication method: Not applicable as no clinical test set/ground truth is described.
- MRMC comparative effectiveness study: No such study is mentioned. The device is a laser system, not an AI-assisted diagnostic tool.
- Standalone performance: The document deals with a physical medical device, not a standalone algorithm.
- Type of ground truth used: Not applicable as no clinical endpoints are being evaluated against a ground truth.
- Sample size for the training set: No training set for an algorithm is described.
- How ground truth for the training set was established: Not applicable.
The document does include the following relevant information:
- Nonclinical tests submitted: Sterilization Validation.
- Conclusions drawn from non-clinical data: An Autoclave Sterilization Validation of the 10 x 10 and 6 x 6 Focal Guide Assemblies was conducted. The test articles, negative controls, and environmental controls all exhibited no growth of G. stearothermophilus after being subjected to 3 half cycle rounds of specific gravity cycle settings, meeting an SAL of ≤10⁻⁶. Functional testing showed that the sterilization did not affect device function. This indicates the device meets sterilization efficacy standards.
In summary, this document is a regulatory submission for substantial equivalence based on technological similarity and non-clinical safety (sterilization). It does not present a clinical study with acceptance criteria for performance related to its intended aesthetic and dermatological uses.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.