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The CoolTouch Model LC215 Nd:YAG Surgical Laser is indicated for the following: a) for use in dermatology for incision, excision, ablation and vaporization with hemostasis of soft tissue; b) for use in the treatment of fine lines and wrinkles; c) for treatment of back acne and atrophic acne scars, and; d) for treatment of reflux of the great and small saphenous veins associated with varietse veins and varicosities.

The LC215 Nd: YAG Laser System produces laser emission at 1320nm. The laser 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 or JouleTracker

The CoolTouch LC215 Nd:YAG Laser System is a surgical laser device. The provided documents focus on its substantial equivalence to a predicate device rather than on performance studies with specific acceptance criteria. Therefore, most of the requested information about device performance and studies is not available in these documents.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not available. The submission is a 510(k) Pre-market Notification, which primarily establishes substantial equivalence to a legally marketed predicate device (CoolTouch CT3S Nd:YAG Laser System). It does not present specific performance criteria or a study demonstrating the device meets those criteria. The document explicitly states "Performance Data: None".

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. No performance study data is presented for a test set.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. No performance study data is presented for a test set requiring ground truth established by experts.

4. Adjudication Method for the Test Set

Not applicable. No performance study data is presented for a test set requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The documents do not mention an MRMC comparative effectiveness study.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a physical laser system, not an algorithm, so standalone performance in this context is not relevant.

7. Type of Ground Truth Used

Not applicable. No performance study data is presented for a test set requiring ground truth. The submission relies on demonstrating substantial equivalence to a predicate device for safety and effectiveness.

8. Sample Size for the Training Set

Not applicable. No machine learning or algorithmic training set is mentioned as this is a physical medical device.

9. How the Ground Truth for the Training Set Was Established

Not applicable. No machine learning or algorithmic training set is mentioned.

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