(207 days)
The Fraxel III SR Laser System and accessories is intended for use in:
Dermatological procedures requiring ablation (removal), coagulation and resurfacing of soft tissue.
The Fraxel III SR Laser System consists of a laser source which delivers a pattern of thermal energy to the epidermis and dermis using scanning and focusing optics. Device accessories include interchangeable treatment tips.
The provided text describes the 510(k) summary for the Fraxel III SR Laser System. However, it does not contain the specific details required to complete your request regarding acceptance criteria and a detailed study.
The document states:
- "Clinical analysis was conducted on Non-Significant Risk and Investigational Device Exemption studies to support the clinical performance of the Fraxel III SR Laser System. Sufficient safety data has been gathered to determine that the Fraxel III Laser System and Accessories performs as clinically intended and that no new issues of safety and effectiveness are introduced."
This indicates that clinical studies were performed, and favorable safety data was collected, but the specific metrics, acceptance criteria, sample sizes, expert details, or study methodology (e.g., MRMC, standalone) are not provided in this summary.
Therefore, I cannot fill out the detailed tables and information sections you requested based solely on the provided text. The document focuses on regulatory approval based on "substantial equivalence" to predicate devices rather than a detailed report of a specific clinical trial's performance metrics against predefined 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.