510(k) Report

Devices descending from K152889

3 later devices reach Sonilase Blue, Sonilase Blue-Clean, Sonilase Blue-UV Clean Plus through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170260BC-001+ Acne PurifierOriental Inspiration Limited20172—
+2K220729The Luminance RED Acne DeviceLuminance Medical Ventures, Inc.20221—
+3K251843Erchonia EVRLErchonia Corporation20250—