Search Results

The SmoothCool HR System is indicated for hair removal (permanent hair reduction).

SmoothCool HR System is an Intense Pulsed Light (IPL) system used for hair removal (permanent hair reduction) in the area of dermatology. The system consists of a console containing the power unit and control electronics with control and display panel including software. Applicators/hand pieces are connected to the system in order to generate light energy for treatment. Four different hand pieces are offered with the system.

The provided document is a 510(k) summary for the SmoothCool HR System, which is an Intense Pulsed Light (IPL) system for hair removal. It aims to demonstrate substantial equivalence to predicate devices, not to describe the acceptance criteria and study that proves the device meets those criteria in the way typically associated with AI/ML-based medical devices or diagnostic devices involving performance metrics like sensitivity, specificity, or AUC.

Therefore, the specific information requested in the prompt (e.g., acceptance criteria table, sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth type, training set sample size, how ground truth was established for training set) is not present in this document.

This document focuses on regulatory equivalence for a hardware device (IPL system) based on updated components and technical characteristics rather than a software algorithm's performance against clinical endpoints or expert consensus. The "tests" mentioned are for energy output and electrical safety/EMC, which are standard for such physical devices, not performance evaluation against clinical outcomes or a ground truth as would be relevant for devices that interpret data or diagnose conditions.

Ask a specific question about this device