(57 days)
The CoolTouch CT3 ND:YAG Laser System is indicated for treatment of back acne and treatment of atrophic acne scars
The CoolTouch Incorporated CoolTouch CT3 Nd:YAG Surgical Lasers are lasers producing emissions at 1320nm. The lasers consist of several interconnected sections: the cabinet, which houses the power supply, cooling system, microcontroller, and the laser head, the fiber optics, and the handpiece. The systems provide safety features that are designed to protect the user and patient from high voltages and laser emissions.
The provided text does not contain information about acceptance criteria or a study proving the device meets them. The document is a 510(k) summary for the CoolTouch CT3 laser systems, focusing on its substantial equivalence to a predicate device for specific indications (treatment of back acne and atrophic acne scars). It mentions compliance with certain CFR sections but does not detail performance metrics, study designs, sample sizes, or ground truth establishment.
§ 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.