(80 days)
The IPL Hair Removal Device is an over-the-counter device used to remove excess hairs for home or medical institution use.
Not Found
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.
§ 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.