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1064nm mode is indicated for the removal or lightening of unwanted facial or body hair, for skin resurfacing (ablation of epidermal skin layers) in dermatology and aesthetic surgery, benign pigmented lesions (dermal melanocytosis) and tattoo removal for dark and blue inks.

The 1064nm fractional mode is indicated for the treatment of wrinkles in Fitzpatrick Skin Types I-IV.

532 nm mode is indicated for tattoo removal including red, blue and light blue and green inks, for the treatment of benign vascular lesions including telangiectasias, spider angiomas, cherry angiomas, spider nevi and the treatment of benign pigmented lesions including Cafe-au-lait birthmarks, solar lentigines, Becker's nevi, freckles nevus spilus and nevus of ota. 532nm mode is also indicated for incision, excision, ablation and vaporization of soft tissue in general dermatology.

The Iris Diode is intended for use for vascular lesions, spider veins, spider naevi, teleangiectasis, red superficial veins of the legs and face, pigmented lesions (e.g. cafe-au-lait stains, lentigo), hemangiomas, port wine stains, rosacea.

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I am sorry, but the provided FDA 510(k) clearance letter for the Alma Harmony Laser Device (K243044) does not contain the detailed information required to answer your request regarding acceptance criteria and the study that proves the device meets those criteria.

The letter primarily focuses on:

• Confirming the substantial equivalence determination for the device based on its indications for use.
• Listing relevant regulations and requirements for medical device manufacturers.
• Providing contact information for regulatory inquiries.
• Stating that the submitter will make information on safety and effectiveness available upon request.

Here's what is missing from the provided text that would be necessary to answer your specific questions:

• Acceptance Criteria: The document does not define any specific performance metrics (e.g., sensitivity, specificity, accuracy, precision, power output tolerances, treatment efficacy rates) that the device must meet, nor does it list numerical targets for these metrics. Laser devices typically have performance specifications related to wavelength, energy, pulse duration, spot size, etc., but these are not present as acceptance criteria in this document.
• Study Design and Results: There is no mention of a clinical or technical study conducted to prove the device meets performance criteria. The letter doesn't include:
  • Performance data: No tables of reported device performance.
  • Sample size and data provenance: No details on test sets, training sets, or where data came from.
  • Ground truth establishment: No information on how ground truth was determined (e.g., expert consensus, pathology, outcomes).
  • Expert qualifications or adjudication: No details on experts, their number, or adjudication methods.
  • MRMC or standalone studies: No mention of these types of studies or their outcomes.
  • Effect size of AI assistance: Not applicable as this is a laser device, not an AI diagnostic tool.

In summary, to answer your questions, I would need a different type of document, such as:

• The 510(k) summary document itself: Submissions typically include a summary of the data and methods used to demonstrate substantial equivalence, which might contain some of this information.
• Clinical study reports: Detailed reports of any studies conducted.
• Performance testing protocols and results.

Without this information, I cannot fulfill your request.

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