(214 days)
The LunulaLaser™ device is indicated for use for the temporary increase of clear nail in patients with onychomyosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.)
Not Found
This document is a 510(k) clearance letter for the LunulaLaser, a Class II medical device. It does not provide information on acceptance criteria or a study that proves the device meets those criteria. Instead, it confirms that the FDA reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices for the indication of temporary increase of clear nail in patients with onychomycosis.
Therefore, I cannot extract the requested information based on the provided text. The document is administrative in nature, approving the device for marketing based on substantial equivalence, rather than detailing a performance study with acceptance criteria.
§ 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.