510(k) Report

Devices descending from K063384

13 later devices reach Diodent Micro Dental Laser System, Models 810 and 980 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K163638Dental 5 Multi Diode laserBio-Med USA, Inc.20170—
+1K093048D-Storm 810NM, D-Storm 980NMLight Instruments20100—
+1K100474Quicklasedual+, QUICKLASE810, QUICKLASE810, QUICKLASE980, QUICKLASE980 Model: 3W,5W,3W,5WQuicklase Limited20108—
+1K082445CURATIVE980 Diode LaserOroscience, Inc.20080—
+1K073332V-Raser Diode Laser SystemHoya Conbio, Inc.20080—
+2K232222Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)Medency S.R.L.20230—
+2K193486Epic 980Biolase, Inc.20202—
+2K152032ELUMI 810 + 980 Soft Tissue LaserAzena Medical, LLC20157—
+3K234085LUNE™ PureHygieneEnamel Pure20241—
+3K192617Gemini 810+980 Soft Tissue LaserAzena Medical, LLC20202—
+4K260138LUNE PureHygieneEnamel Pure20260—
+4K210350Gemini 2 810+980 Soft Tissue LaserAzena Medical, LLC20211—
+5K260765Gemini NOVA 810+980 Soft Tissue LaserAzena Medical, LLC20260—