(233 days)
The ESC Diode Laser System is intended for the treatment of vascular and pigmented lesions including leg veins.
The ESC Diode Laser System is a semiconductor diode laser system operating at the 830nm wavelength
This 510(k) premarket notification for the ESC Diode Laser System does not contain the detailed information necessary to complete the requested table and study description. This document focuses on demonstrating substantial equivalence to predicate devices based on technical specifications and intended use, rather than presenting a performance study with acceptance criteria and results for the device itself.
Here's why the requested information cannot be fully provided from the given text:
- No specific acceptance criteria are defined or reported. The document states the device "conforms with federal regulations and the performance standards 21 CFR 1040.10 and 1040.11 for medical laser systems," but these are general safety and performance standards, not specific clinical or technical acceptance criteria with measurable metrics (e.g., specific treatment success rates, lesion clearance percentages, etc.) that would typically be found in a performance study.
- No performance study is detailed. The document does not describe any clinical or technical study conducted to evaluate the ESC Diode Laser System against specific performance metrics or acceptance criteria. It primarily focuses on comparing the device to existing predicate devices based on general characteristics.
- The document is a 510(k) summary and FDA letter, not a clinical study report. These types of documents aim to demonstrate equivalence for regulatory approval, not to present the results of a dedicated clinical trial or performance evaluation with all the requested details.
Therefore, I cannot populate the table or answer the questions related to acceptance criteria, study design, sample sizes, expert involvement, adjudication, or ground truth establishment. These elements are not provided in the supplied 510(k) documentation.
§ 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.