(113 days)
The IPL Hair Removal Device is an over-the-counter device used to remove excess hairs for adults, suitable for home or medical institution use. The device is used for adults with Fitzpatrick skin types I-IV.
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I am sorry, but based on the provided text, there is no information about acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies related to the IPL Hair Removal Device.
The text is a 510(k) clearance letter from the FDA, confirming that the device is substantially equivalent to legally marketed predicate devices. It outlines regulatory requirements and provides contact information but does not contain the specific study results or performance data you are requesting.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.