510(k) Report

Devices descending from K111840

3 later devices reach Emerge Fractional Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230077LaserMENeauvia North America20232—
+2K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+3K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—