(22 days)
The DioDerm Laser is intended for use in dermatology for photocoagulation of vascular lesions.
Not Found
I am sorry, but the provided text does not contain the information requested in your prompt. The document is an FDA 510(k) clearance letter for the Cynosure DioDerm Laser, indicating that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory information, labeling, and general responsibilities under the Act.
There is no mention of:
- Acceptance criteria or reported device performance in a table.
- Details of any study (sample size, data provenance, number or qualifications of experts, adjudication method).
- Any multi-reader multi-case (MRMC) comparative effectiveness study, effect size, or human-in-the-loop performance.
- Standalone algorithm performance.
- Type of ground truth used.
- Training set size or how its ground truth was established.
Therefore, I cannot fulfill your request based on the provided input.
§ 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.