510(k) Report

Devices descending from K912383

157 later devices reach Vibratouch II Cordless Wand Massager through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K243139Reverso Pro SystemIndiba S. A. U.20250—
+6K243929Oligio XWontech Co., Ltd.20250—
+6K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+6K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+6K231495The Evolve System with the Transform ApplicatorInMode, Ltd.20231—
+6K230167BACK 4Swims America Corp20230—
+6K230037BACK 3Swims America Corp20230—
+6K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+6K192224BTL-899Btl20198—
+6K180709truSculpt RF Device; truSculpt; truSculpt 3DCutera, Inc.20183—
+6K172004truSculptCutera, Inc.20173—
+6K161198Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3Usa Laser Biotech, Inc.20160—
+6K152731XP1100 RFBTL Industries, Inc.20160—
+6K160947LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX…Usa Laser Biotech, Inc.20160—
+6K150724SculpSureCynosure, Inc.201521—
+6K150230SculpSureCynosure, Inc.201521—
+6K143741Lipofina Laser SystemYolo Medical, Inc.20153—
+6K130341Strawberry, Strawberry & CreamLaser Lipo Limited201312—
+7K250200InbellaBody SystemInbella Medical, Inc.20250—
+7K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+7K221407truSculpt iDCutera, Inc.20222—
+7K213534PHantom TrilogyResurgeonz, LLC20220—
+7K202955Contour Light CL-100Contour Research, LLC20218—
+7K202199BTL-899STBtl20216—
+7K192275invisa-RED ELITEIR Technology, LLC20201—
+7K191068Powersculp laser lipolysis systemWuhan Lotuxs Technology Co., Ltd.20196—
+7K170709CURVE Laser SystemYolo Medical, Inc.20170—
+7K160470SculpSureCynosure, Inc.201620—
+7K134040BTL-9000; BTL-9000 Radiofrequency ModuleBtl Industries, Ltd.20140—
+8K260688Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+8K243854Contour Light (CL-100)Contour Research, LLC20261—
+8K252786Led Light Phototherapy Bed (Pro 450/ GY-680A)Shenzhen Suyzeko Limited.20250—
+8K232977Biophotas Celluma CONTOURBiophotas, Inc.20235—
+8K223110truSculpt iDCutera, Inc.20221—
+8K222265DiosculptShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20220—
+8K211681EONDominion Aesthetic Technologies, Inc.20221—
+8K212331BodySculpRohrer Aesthetics, LLC20211—
+8K211402Powersculp laser lipolysis systemLotuxs Medtech (Suzhou) Co., Ltd.20210—
+8K211107BTL-899 FPBTL Industries, Inc.20213—
+8K201731Diode Laser Body Sculpture SystemShanghai Apolo Medical Technology Co., Ltd.20201—
+8K171111SculpsureCynosure, Inc.201710—
+9K260129Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )Shenzhen Kaiyan Medical Equipment Co., Ltd.20261—
+9K252888NeoSculpt PlusS&M Medical Co., Ltd.20260—
+9K251781Kala Mini 2.0 (Kala-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+9K241947EnergyLounger (TY-01)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+9K233099GladiatorRohrer Aesthetics, LLC20240—
+9K2406581060nm laser body slimming machineHebei JT Medical Co., Ltd.20240—
+9K222226EONDominion Aesthetic Technologies, Inc.20230—
+9K213344BTL-899ABTL Industries, Inc.20222—
+9K192970SlimusHironic Co., Ltd.20200—
+9K171992SculpSureCynosure, Inc.20178—
+10K260715CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd.20260—
+10K231971Deka Physiq 360El.En S.P.A.20230—
+10K230467BTL-899FBTL Industries, Inc.20231—
+10K182741SculpSureCynosure20195—
+11K233849BTL-499BTL Industries, Inc.20240—
+11K231131Diode Laser Body Sculpture SystemsShanghai Bele Medical Technology Co.,Ltd20230—