510(k) Report

Devices descending from K060069

107 later devices reach Palomar Luxir Fractional Handpiece through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd.20216—
+9K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+9K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+9K241433EVE Synergy (EVE-20M)Weero Co., Ltd.20251—
+9K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+9K230167BACK 4Swims America Corp20230—
+9K230037BACK 3Swims America Corp20230—