510(k) Report

Devices descending from K103664

7 later devices reach Primus Aesthetic Platform through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153229SuperbiumBios S.R.L.20162—
+1K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+2K252561BTL-754FFBTL Industries, Inc.20260—
+2K230077LaserMENeauvia North America20232—
+2K163196ACTION II Laser SystemLutronic Corporation20170—
+3K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+4K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—