510(k) Report

Devices descending from K192430

5 later devices reach Epic 980 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.20260—
+1K232222Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)Medency S.R.L.20230—
+1K193486Epic 980Biolase, Inc.20202—
+2K234085LUNE™ PureHygieneEnamel Pure20241—
+3K260138LUNE PureHygieneEnamel Pure20260—