(90 days)
The DermaChiller 4 is intended as a skin-cooling device to minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief for injections.
The DermaChiller consists of a source of a refrigerant fluid controlled by an electronically operated solenoid delivery valve. The refrigerant fluid is sprayed in a controlled fashion onto a sapphire window, which is cooled and applied to skin.
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or a study that proves the device meets those criteria. The document is a 510(k) summary for DermaChiller 4, which outlines its intended use, classification, and substantial equivalence to other devices. It does not include details on clinical trials, effectiveness studies, or performance metrics against specific acceptance criteria.
Therefore, I cannot fulfill your request for the table and study details.
§ 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.