510(k) Report

Devices descending from K090525

9 later devices reach Loi System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K163137NIRA Beauty Skin LaserDermal Photonics Corporation20171—
+1K130459Tria Fan SystemTria Beauty, Inc.20131—
+1K130793Newa Skin Therapy SystemEndymion Medical, Ltd.20130—
+1K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+2K230077LaserMENeauvia North America20232—
+2K222685NIRA Model 2Dermal Photonics Corp20230—
+2K141868Tria FanpTria Beauty, Inc.20140—
+3K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+4K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—