510(k) Report

Devices descending from K152032

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232222Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)Medency S.R.L.20230—
+1K193486Epic 980Biolase, Inc.20202—
+1K192617Gemini 810+980 Soft Tissue LaserAzena Medical, LLC20202—
+2K234085LUNE™ PureHygieneEnamel Pure20241—
+2K210350Gemini 2 810+980 Soft Tissue LaserAzena Medical, LLC20211—
+3K260138LUNE PureHygieneEnamel Pure20260—
+3K260765Gemini NOVA 810+980 Soft Tissue LaserAzena Medical, LLC20260—