510(k) Report

Devices descending from K050397

150 later devices reach Velasmooth, Shaper through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+5K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+5K250734OptiLUV DevicePollogen, Ltd.20250—
+5K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+5K241433EVE Synergy (EVE-20M)Weero Co., Ltd.20251—
+5K250200InbellaBody SystemInbella Medical, Inc.20250—
+5K243139Reverso Pro SystemIndiba S. A. U.20250—
+5K243929Oligio XWontech Co., Ltd.20250—
+5K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+5K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+5K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+5K230167BACK 4Swims America Corp20230—
+5K230037BACK 3Swims America Corp20230—
+5K221407truSculpt iDCutera, Inc.20222—
+5K213534PHantom TrilogyResurgeonz, LLC20220—
+5K202955Contour Light CL-100Contour Research, LLC20218—
+5K202199BTL-899STBtl20216—
+5K192275invisa-RED ELITEIR Technology, LLC20201—
+5K191068Powersculp laser lipolysis systemWuhan Lotuxs Technology Co., Ltd.20196—
+5K170709CURVE Laser SystemYolo Medical, Inc.20170—
+5K160470SculpSureCynosure, Inc.201620—
+5K134040BTL-9000; BTL-9000 Radiofrequency ModuleBtl Industries, Ltd.20140—
+6K260688Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+6K243854Contour Light (CL-100)Contour Research, LLC20261—
+6K252786Led Light Phototherapy Bed (Pro 450/ GY-680A)Shenzhen Suyzeko Limited.20250—
+6K232977Biophotas Celluma CONTOURBiophotas, Inc.20235—
+6K223110truSculpt iDCutera, Inc.20221—
+6K222265DiosculptShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20220—
+6K211681EONDominion Aesthetic Technologies, Inc.20221—
+6K212331BodySculpRohrer Aesthetics, LLC20211—
+6K211402Powersculp laser lipolysis systemLotuxs Medtech (Suzhou) Co., Ltd.20210—
+6K211107BTL-899 FPBTL Industries, Inc.20213—
+6K201731Diode Laser Body Sculpture SystemShanghai Apolo Medical Technology Co., Ltd.20201—
+6K171111SculpsureCynosure, Inc.201710—
+7K260129Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )Shenzhen Kaiyan Medical Equipment Co., Ltd.20261—
+7K252888NeoSculpt PlusS&M Medical Co., Ltd.20260—
+7K251781Kala Mini 2.0 (Kala-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+7K241947EnergyLounger (TY-01)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+7K233099GladiatorRohrer Aesthetics, LLC20240—
+7K2406581060nm laser body slimming machineHebei JT Medical Co., Ltd.20240—
+7K222226EONDominion Aesthetic Technologies, Inc.20230—
+7K213344BTL-899ABTL Industries, Inc.20222—
+7K192970SlimusHironic Co., Ltd.20200—
+7K171992SculpSureCynosure, Inc.20178—
+8K260715CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd.20260—
+8K231971Deka Physiq 360El.En S.P.A.20230—
+8K230467BTL-899FBTL Industries, Inc.20231—
+8K182741SculpSureCynosure20195—
+9K233849BTL-499BTL Industries, Inc.20240—
+9K231131Diode Laser Body Sculpture SystemsShanghai Bele Medical Technology Co.,Ltd20230—