510(k) Report

Devices descending from K192617

2 later devices reach Gemini 810+980 Soft Tissue Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K210350Gemini 2 810+980 Soft Tissue LaserAzena Medical, LLC20211—
+2K260765Gemini NOVA 810+980 Soft Tissue LaserAzena Medical, LLC20260—