510(k) Report

Devices descending from K950493

1,051 later devices reach Photoderm VL. through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+11K240999Legend X Applicator VOPollogen, Ltd.20241—
+11K233849BTL-499BTL Industries, Inc.20240—
+11K233604BTL-785SBTL Industries, Inc.20243—
+11K230837PlazMagikAgnes Medical Co., Ltd.20240—
+11K232223PlaDuo SystemShenB Co., Ltd.20230—
+11K230167BACK 4Swims America Corp20230—
+11K231790The InMode System with the Morpheus8 ApplicatorsInMode, Ltd.202310—
+11K230037BACK 3Swims America Corp20230—
+11K230124LUSTRE ClearSkin Renew Pro Facewear Mask (Model: PR4001)Light Tree Ventures Europe B.V.202310—
+11K223404Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4VQuanta System Spa20230—
+11K212472AgeJetTriworks Group Srl20220—
+11K213726PL-1 Skin Treatment SystemAVAVA, Inc.20220—
+11K211681EONDominion Aesthetic Technologies, Inc.20221—
+11K191068Powersculp laser lipolysis systemWuhan Lotuxs Technology Co., Ltd.20196—
+11K190743Venus BlissVenus Concept USA, Inc.20194—
+11K171111SculpsureCynosure, Inc.201710—
+11K162050ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201614—
+12K254185Potenza PrimeJeisys Medical Incorporated20260—
+12K253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.20260—
+12K253484Lutronic GeniusCynosure Lutronic Technology Corporation20260—
+12K253803MILAN SystemLumenis Be, Ltd.20260—
+12K253750BTL-785NEHBTL Industries, Inc.20260—
+12K251435InbellaIgnite RF SystemInbella Medical, Inc.20260—
+12K251254Ignite RF SystemInMode, Ltd.20260—
+12K252367InbellaMulti SystemInbella Medical, Inc.20250—
+12K242469RFMagik LiteAgnes Medical Co., Ltd.20252—
+12K242532BTL-785BNF-EBTL Industries, Inc.20241—
+12K233962ReBorn (1050nm)Lightfective, Ltd.20240—
+12K233642InMode RF SystemInMode, Ltd.20244—
+12K222226EONDominion Aesthetic Technologies, Inc.20230—
+12K222265DiosculptShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20220—
+12K213308Venus BlissMAXVenus Concept USA, Inc.20222—
+12K212331BodySculpRohrer Aesthetics, LLC20211—
+12K211402Powersculp laser lipolysis systemLotuxs Medtech (Suzhou) Co., Ltd.20210—
+12K192970SlimusHironic Co., Ltd.20200—
+12K201731Diode Laser Body Sculpture SystemShanghai Apolo Medical Technology Co., Ltd.20201—
+12K171992SculpSureCynosure, Inc.20178—
+12K171069ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.20178—
+13K250217AGNES UltraAgnes Medical Co., Ltd.20250—
+13K243713Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A…Agnes Medical Co., Ltd.20250—
+13K240780InMode RF SystemInMode, Ltd.20243—
+13K2406581060nm laser body slimming machineHebei JT Medical Co., Ltd.20240—
+13K231971Deka Physiq 360El.En S.P.A.20230—
+13K220592Venus BlissMAXVenus Concept USA, Inc.20221—
+13K182741SculpSureCynosure20195—
+13K172144CoolSculpting SystemZeltiq Aesthetics20177—
+14K252845Venus Nova (FP-2001)Venus Concept, Inc.20250—
+14K243737Inbella RF SystemInbella Medical, Inc.20250—
+14K231131Diode Laser Body Sculpture SystemsShanghai Bele Medical Technology Co.,Ltd20230—
+14K181740ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201805