Search Results

For use in dermatology for incision, excision, ablation and vaporization with hemostasis of soft tissue. For use in the treatment of fine lines and wrinkles.

The New Star CoolTouch® Nd:YAG Surgical Laser Systems are ND:YAG lasers producing laser emission at 1320 nm. The lasers consists of three interconnected sections: The cabinet which houses the power supply, the cooling system, the microcontroller and the laser, the fiber optics and the handpiece.

The provided text is a 510(k) Summary for a medical device, the "New Star Nd:YAG Surgical Laser Model CoolTouch® 3". It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document explicitly states "Performance Data: None".

Therefore, the following information cannot be provided from the given text:

• Acceptance criteria and reported device performance: No performance data is reported, and thus no acceptance criteria are mentioned.
• Sample size used for the test set and data provenance: No test set was used for performance evaluation.
• Number of experts used to establish the ground truth for the test set and their qualifications: No ground truth was established for performance evaluation.
• Adjudication method for the test set: No test set adjudication occurred.
• Multi-reader multi-case (MRMC) comparative effectiveness study: No such study was conducted.
• Standalone (algorithm only without human-in-the-loop performance) study: This device is a laser system, not an algorithm. No such study was conducted.
• Type of ground truth used: No ground truth was used for performance evaluation.
• Sample size for the training set: This device is a laser system, not an AI/ML algorithm requiring a training set.
• How the ground truth for the training set was established: Not applicable.

Conclusion:

The submission for the New Star Nd:YAG Surgical Laser Model CoolTouch® 3 relies on substantial equivalence to existing predicate devices (New Star Lasers, Inc. Model NS-130 (CoolTouch®) and Model CoolTouch® II Nd:YAG Laser Systems) rather than presenting new performance data or a study to meet specific acceptance criteria. The document explicitly states "Performance Data: None," indicating that no clinical or technical performance study was conducted or reported to define and meet specific acceptance criteria for this particular 510(k) submission.

Ask a specific question about this device