510(k) Report

Devices descending from K142376

13 later devices reach Palomar Icon Aesthetic System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241270BTL-754BTL Industries, Inc.20251—
+1K173285Joule SystemSciton, Inc20185—
+1K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+2K252561BTL-754FFBTL Industries, Inc.20260—
+2K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+2K192856MT OneM&T S.R.L.20202—
+2K180508Joule SystemSciton, Inc20183—
+2K180406Ellipse YdunEllipse A/S20180—
+3K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+3K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+3K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+3K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+3K210847UltraClear Fractional Laser SystemFa International, LP20210—