510(k) Report

Devices descending from K150516

16 later devices reach Deka Synchro Repla:Y Family of Laser Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233090DEKA AGAIN PRO familyEl.En S.P.A.20232—
+1K193426Elite iQCynosure, LLC20201—
+1K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+1K181486DEKA Motus AYEl.En Electronic Engineering Spa20182—
+1K162886Deka Motus AXEl.En Electronic Engineering Spa20171—
+1K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.20161—
+2K243630Medical Laser System Incanto / Evoline Platinum /EvolineSolar LS Cjsc20250—
+2K241407Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)Bios S.R.L.20240—
+2K234057NirvanaEl.En S.P.A.20240—
+2K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+2K223540AvalancheLase FamilyFotona D.O.O.20230—
+2K22079410PLTentech Co., Ltd.20220—
+2K212790XLase PlusBiotec Italia, Srl20220—
+2K211821DEKA Motus AZEl.En Electronic Engineering Spa20211—
+2K200616E>EyeCE-Swin20200—
+3K241459MOTUS PRO FamilyEl.En S.P.A.20240—