(100 days)
The V-Laser laser system is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery.
The V-Laser is a Nd: YAG laser operating at wavelengths of 1,064 nm and 532 nm. The V-Laser consists of the main body, optical fiber cable, user-undetachable laser handpiece tip, footswitch, and handpiece cable cradle. The laser output is delivered to the skin through the optical fiber terminated by the handpiece. The fluence (energy density), frequency and pulse are controlled from the LCD display/Touch Pad located on the front of the main unit. The LCD display is used to obtain feedback from the system, such as the number of pulses delivered or spot size selected.
This document is a 510(k) summary for the WON TECH Co., Ltd. V-Laser, a laser surgical instrument. The document states that no clinical studies were performed, and therefore, it does not contain the information required to fulfill the request.
Here's why the requested information cannot be provided based on the input:
- Acceptance Criteria and Reported Device Performance: The document lists technical specifications for the V-Laser and compares them to a predicate device (K183156). It notes differences in spot size and cooling system and states that these differences do not affect intended use, safety, or effectiveness. However, it does not define specific "acceptance criteria" for clinical performance (e.g., success rates, adverse event rates) or present "reported device performance" against such criteria.
- Sample Size, Data Provenance, Number of Experts, Adjudication Method, MRMC Study, Standalone Performance, Ground Truth Type, Training Set Sample Size, Training Set Ground Truth: All these points relate to clinical studies involving human subjects and the evaluation of the device's efficacy and safety in a real-world setting. The document explicitly states: "No clinical studies were considered necessary and performed."
Therefore, all the requested information related to clinical studies and performance metrics based on such studies is absent from this document. The submission focuses solely on demonstrating substantial equivalence to a predicate device through non-clinical testing (electrical safety, EMC, software validation, biocompatibility) and a comparison of technical specifications.
§ 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.