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The PhotoGenica YLV laser is used for the treatment of benign cutaneous vascular and vascular dependent lesions.

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I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is a clearance letter from the FDA for a device called "Cynosure PhotoGenica VLV Cutaneous Vascular Lesion Laser," indicating that it has been determined to be substantially equivalent to devices marketed prior to May 28, 1976.

The letter mentions:

• Trade Name: Cynosure PhotoGenica VLV Cutaneous Vascular Lesion Laser
• Regulatory Class: II
• Product Code: GEX
• Indications For Use: The PhotoGenica YLV laser is used for the treatment of benign cutaneous vascular and vascular dependent lesions.

However, it does not include details on:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study or effect size.
6. Standalone performance study.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document serves as an FDA clearance notification rather than a detailed technical report or study summary.

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