YellowStar

YellowStar is a laser surgical instrument intended for the treatment of benign vascular and benign pigmented lesions. It is a Class II device equipped with a high-power optically pumped semiconductor laser (HOPSL) that emits 577nm wavelength light at up to 8W output power, with pulse durations from 2 ms to 150 ms and continuous wave modes, delivered via handpieces (focusing or scanner) connected by optical fiber.

YellowStar operates at 577nm wavelength only (versus predicate QuadroStarPRO at 532 or 577nm), delivers 8W maximum power (predicate: 8W @ 532nm, 5W @ 577nm), has pulse duration of 2-150ms and CW (predicate: 1ms-95s and CW), spot size 0.5-1.5mm handpieces or 1mm scanner (predicate: 0.5-2.8mm handpieces or 1mm scanner), and maintains 20 Hz repetition rate matching the predicate.

IEC 60601-1:2005 with amendments (general medical electrical safety), IEC 60601-1-2:2005 with amendments (electromagnetic compatibility), IEC 62304:2006 with amendments (medical device software), IEC 62366-1:2015 with amendments (usability engineering), IEC 60601-2-22:2019 (laser equipment safety), and ISO 14971:2019 (risk management). Software verification and validation followed FDA guidance for software in medical devices.

YellowStar is substantially equivalent to the predicate QuadroStarPRO (K133297) because both devices share the same intended use (treating benign vascular and pigmented lesions), same fundamental laser technology, and comparable operational parameters. The differences (single 577nm wavelength, narrower pulse duration range, and refined spot size specifications) do not raise new safety or effectiveness concerns. The device underwent and passed all required performance testing and software validation per applicable standards, demonstrating it performs as safely and effectively as the legally marketed predicate device.