(49 days)
NEOSALUS Lotion is indicated for management of various types of dermatoses, including atopic dermatitis and allergic contact dermatitis.
NEOSALUS Lotion is fragrance-free, water-soluble dressing formulated for the management and relief of irritation experienced with various types of dermatoses including atopic dermatitis and allergic contact dermatitis. NEOSALUS Lotion is intended for topical application.
The provided text pertains to a 510(k) premarket notification for NEOSALUS Lotion. However, it does not describe any specific performance study, acceptance criteria, or experimental results that would fit the requested categories. The document is a regulatory summary and notification of substantial equivalence, not a detailed performance study report.
Therefore, I cannot provide the requested information from the given text. The document explicitly states:
"Performance Data: The predicate device referenced is non-sterile formulation that is applied topically to relieve the symptoms of various types of dermatoses."
This indicates that new performance data for NEOSALUS Lotion was not provided as part of this 510(k) submission. Instead, the device's substantial equivalence was established based on its similarity to a previously cleared predicate device (NEOSALUS Cream K090585) and its intended use.
No study proving the device meets acceptance criteria is described in this document. The summary focuses on comparing the new device to a predicate device, concluding substantial equivalence without presenting new performance data or defining acceptance criteria for such data.
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