Search Results

The Lux1064TM handpiece is indicated for:

• The removal of unwanted hair for skin types I-VI, and to effect . stable long-term permanent hair reduction.
• The treatment of benign pigmented lesions such as, but not t limited to, senile lentigines (age spots), solar lentigos (sun spots), pigmented seborrheic keratoses, nevi, chloasma, caféau-lait macules, and plaques.
• . Verrucae, skin tags, seborrheic keratosis,
• Tattoos (significant reduction in the intensity of black and/or 속 blue-black tattoos).
• The Lux1064™ is indicated for pigmented lessons 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.
• The treatment of vascular lesions such as but not limited to, . port wine stains, hemangiomas, telangiectasias, rosacea, Venus lake, facial and leg veins.
• The Lux10641M is also indicated for the 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.
• Pseudofolliculitis barbae (PFB) ●

The Lux1064™ is a versatile, light-based medical
device consisting of a base unit and handpiece
attachments.

The provided text does not contain specific acceptance criteria or a detailed study description with reported device performance against those criteria. Instead, it is a 510(k) summary and FDA clearance letter for the Palomar Lux1064™ Nd:YAG Handpiece.

Here's what can be extracted and what is missing based on your request:

Missing Information:

The document explicitly states: "The differences in the specifications of the Lux1064™ and the predicate devices do not result in different performance or raise new questions of safety or efficacy." This strongly suggests that a new clinical study with specific acceptance criteria and performance metrics was not conducted for this 510(k) submission. Instead, the submission relies on the substantial equivalence principle, comparing the device to legally marketed predicate devices.

Therefore, the following information cannot be provided from the given text:

• A table of acceptance criteria and the reported device performance: No specific performance metrics or acceptance criteria are defined for this device in the context of a new study.
• Sample size used for the test set and the data provenance: No new test set data is presented.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no new test set is described.
• Adjudication method for the test set: Not applicable.
• 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, as this is not an AI/imaging diagnostic device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
• The sample size for the training set: Not applicable, as this is not a machine learning device.
• How the ground truth for the training set was established: Not applicable.

What is available from the text:

The document confirms that this is a substantial equivalence (510(k)) submission, which means the manufacturer is asserting that their new device is as safe and effective as a legally marketed predicate device, rather than providing new clinical data to prove efficacy.

• Conclusion on Performance (from the document):
  "The differences in the specifications of the Lux1064™ and the predicate devices do not result in different performance or raise new questions of safety or efficacy."
  "Based on the foregoing, the Lux1064™ System is substantially equivalent to the legally-marketed claimed predicate devices, i.e., the Lumenis IPL/NdYAG, Candela GentleYAG, and Laserscope Lyra series."

This statement is the key "proof" of the device meeting "acceptance criteria" in the context of a 510(k) submission, where the "acceptance criteria" is essentially demonstrating substantial equivalence to a predicate device already accepted for the market.

In summary, a detailed study with specific acceptance criteria and performance data for the Palomar Lux1064™ Nd:YAG Handpiece is not provided within this 510(k) submission. Its clearance is based on demonstrating substantial equivalence to existing, legally marketed devices for the stated indications for use.

Ask a specific question about this device