Search Results

The Aurora SR is intended for use in dermatology for treatment of superficial benign vascular and pigmented lesion treatment.
The Aurora SR is indicated for treatment of superficial, benign vascular, and pigmented lesions.

The Aurora SR is a device that is used for treatment of superficial, benign vascular and pigmented lesions. The Aurora SR treatment is based on the principle of selective (electromagnetic) thermolysis. According to this principle, parameters of optical and RF energy (spectrum, exposure duration and energy density) are chosen and optimized to selectively damage pigmented and vascular lesions without damaging the surrounding tissues.

The provided text does not contain information about acceptance criteria or a study proving that the device meets specific performance metrics.

The document is a 510(k) premarket notification for the Aurora SR device, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance study results against predefined acceptance criteria.

The key information provided includes:

• Device Name: Aurora SR
• Intended Use: Treatment of superficial, benign vascular and pigmented lesions.
• Principle of Operation: Selective (electromagnetic) thermolysis using optical and RF energy.
• Predicate Devices: PhotoDerm VL, PhotoDerm PL, ThermaCool, Vnus Closure System.
• Conclusion: The manufacturer believes no significant differences exist and the device should raise no new issues of safety or effectiveness.
• FDA Response: The FDA determined substantial equivalence based on the provided indications for use.

Therefore, I cannot fulfill the request for a table of acceptance criteria, device performance, sample sizes, ground truth details, or study methodology as this information is not present in the provided text.

Ask a specific question about this device