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This sunlamp product is intended exclusively for cosmetic tanning of the human skin.

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Given the provided documents, I am unable to describe the acceptance criteria and the study that proves the device meets those criteria. This is because the documents only provide:

• A 510(k) clearance letter for a tanning device (initial documents).
• The Indications for Use for the tanning device (last document).

These documents confirm that the device (E3400 series, E5400 series, E6400 series, Sundazzler series) is cleared for marketing as "exclusively for cosmetic tanning of the human skin." However, they do not contain any information about performance criteria, study designs, sample sizes, ground truth establishment, or expert involvement.

The 510(k) clearance process primarily establishes substantial equivalence to a predicate device. It does not typically require the submission of clinical performance studies with detailed acceptance criteria and statistical analysis in the same way a PMA (Premarket Approval) might, especially for devices like sunlamps where the primary risk mitigate is proper labeling and adherence to performance standards.

Therefore, none of the requested information regarding acceptance criteria or the study proving the device meets them can be extracted from the provided text.

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