(89 days)
The Cynosure Dermatology Laser Cooling Tip is indicated for cooling the skin during dermatology laser treatment procedures.
Not Found
This is a 510(k) clearance letter for the CYNOSURE Dermatology Laser Cooling Tip. This document does not contain any information about acceptance criteria or a study proving the device meets those criteria.
The letter is a regulatory approval, stating that the device is substantially equivalent to legally marketed predicate devices. It does not include performance data, clinical study results, or information on how the device's efficacy or safety was evaluated in terms of specific metrics.
Therefore, I cannot provide the requested information based on the provided 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.