(419 days)
The CoolAn 300 device is intended as a skin-cooling device used to minimize pain and thermal injury during laser and light-based dermatological treatments. Alternative uses include skin cooling as a local topical anesthetic for injections.
CoolAn 300
I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving device performance. The document is a 510(k) clearance letter from the FDA, which confirms that a device (CoolAn 300) is substantially equivalent to a legally marketed predicate device.
While it mentions "indications for use," it does not include:
- A table of acceptance criteria or reported device performance.
- Details about a study, including sample sizes, data provenance, expert qualifications, or adjudication methods.
- Information on MRMC comparative effectiveness studies or standalone algorithm performance.
- How ground truth was established for training or test sets.
Essentially, this document is a regulatory approval, not a scientific study report.
§ 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.