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The LeafPure-Echo is intended for use in surgical and aesthetic application in the medical dermatology and general and plastic surgery as follows:

1064nm wavelength:

• Removal of tattoos on all skin type (Fitzpatrick skin types I-VI) with the following tattoo colours: black, brown, green, blue and purple.
• Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.

532nm wavelength:

• Removal of tattoos on Fitzpatrick skin types I-III with the following tattoo colours: red, yellow and orange.
• Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.

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The WinForth is intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation.

The WinForth massage device is intended to provide a temporary reduction in the appearance of cellulite.

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I am sorry, but the provided text from the FDA 510(k) Clearance Letter for the WinForth (LM-E470KA) device does not contain any information regarding acceptance criteria or the details of a study that proves the device meets such criteria.

The document primarily focuses on:

• The FDA's decision of substantial equivalence to predicate devices.
• General regulatory requirements for the device (e.g., quality system, labeling, adverse event reporting, UDI).
• The intended indications for use of the device.

There is no mention of:

• Specific performance metrics (e.g., accuracy, sensitivity, specificity, or technical performance parameters)
• A trial or study design.
• Sample sizes for test or training sets.
• Number or qualifications of experts.
• Ground truth establishment or type.
• MRMC studies or effect sizes.
• Standalone algorithm performance.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. This type of detailed study information is typically found in the applicant's 510(k) submission summary or a separate clinical/performance study report, not in the FDA clearance letter itself.

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