Search Results

The MCL 29 Dermablate laser is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), and in oral and maxillofacial surgery, and ophthalmology (oculoplasty).

The MCL 29 Dermablate laser is an erbium: YAG of power at 2.94um.

This looks like a 510(k) premarket notification for a medical device, specifically a laser system for soft tissue ablation. In the context of 510(k) submissions, the “acceptance criteria” and “study that proves the device meets the acceptance criteria” often refer to the demonstration of substantial equivalence to a predicate device, rather than a clinical trial with specific performance metrics like sensitivity and specificity for an AI algorithm.

Here's an analysis based on the provided text, addressing your questions where applicable within this regulatory framework:

1. Table of Acceptance Criteria and Reported Device Performance

For 510(k) applications demonstrating substantial equivalence, the "acceptance criteria" are typically that the new device shares basic features, intended use, and similar technological characteristics with a legally marketed predicate device, and does not raise different questions of safety and effectiveness.

In this document, the "performance" is assessed by comparing the specifications and intended use of the MCL 29 Dermablate laser with two predicate devices.

Ask a specific question about this device