510(k) Report

Devices descending from K043255

25 later devices reach Ellipse Light SPT through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K060516Ellipse 12PL, Model 9ESL7228Danish Dermatologic Development A/S200612—
+1K052991Radiancy Facial Skincare DeviceRadiancy (Israel), Ltd.20060—
+1K052688Ellipse Flex PPT, Model 9ESF7255Danish Dermatologic Development A/S200523—
+2K153717Venus Versa SystemVenus Concept, Ltd.20161—
+2K152790Venus Versa SystemVenus Concept, Ltd.20160—
+2K140670Ellipse I2PL+/Ellipse Multiflex+Ellipse A/S201461
+2K112669Tattoostar Effect YAsclepion Laser Technologies GmbH20128—
+2K090724OR-LightYperion Technology20090—
+2K081408Ellipse MultiflexEllipse A/S20087—
+2K061720CosmelightPenntack Enterprises, Inc.20070—
+3K232192Venus Versa PRO SystemVenus Concept, Inc.20230—
+3K173692D-Actor 200 Vibration Massage SystemStorz Medical AG20186—
+3K150907Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner…Ellipse A/S20155—
+3K131757Tattoostar Effect ComboAsclepion Laser Technologies GmbH20140—
+4K243488Vmat ProTermosalud20250—
+4K221865BTL-094BTL Industries, Inc.20230—
+4K210166Omnispec ED1000Medispec, Ltd.20230—
+4K220538DolorClast RadialE.M.S Electro Medical Systems S.A20221—
+4K210451OrthoGold 100Tissue Regeneration Technologies, LLC20212—
+4K192856MT OneM&T S.R.L.20202—
+4K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+5K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+5K213120OW100S (model OW100S-US)Tissue Regeneration Technologies, LLC Dba AS Softwave Trt20220—
+5K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+5K180406Ellipse YdunEllipse A/S20180—