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510(k) Data Aggregation
(80 days)
The IPL Hair Removal Device is an over-the-counter device used to remove excess hairs for home or medical institution use.
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The provided text describes an FDA 510(k) clearance for an IPL Hair Removal Device. It does not contain any information about acceptance criteria or a study that proves the device meets such criteria.
The document is a clearance letter and an Indications for Use statement, which confirm the device's substantial equivalence to predicate devices and state its intended use as an over-the-counter hair removal device for home or medical institution use.
Therefore, I cannot provide the requested information as it is not present in the given text.
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