510(k) Report

Devices descending from K980537

1,242 later devices reach ND: Yag Accessory for Photoderm System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K210129RF Thermal SystemLuvo Medical Technologies, Inc.20211—
+10K210877Evolve System with the T3 ApplicatorInMode, Ltd.20215—
+10K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd.20216—
+10K202503ChromeQuanta System Spa202012—
+10K160470SculpSureCynosure, Inc.201620—
+10K160259ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201615—
+10K150724SculpSureCynosure, Inc.201521—
+10K150230SculpSureCynosure, Inc.201521—
+11K261701Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8)Micro-Energy Medical Technology Co., Ltd.20260—
+11K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+11K253965CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight…Wuhan PHOMED Technology Company, Ltd.20260—
+11K241433EVE Synergy (EVE-20M)Weero Co., Ltd.20251—
+11K243737Inbella RF SystemInbella Medical, Inc.20250—
+11K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+11K230467BTL-899FBTL Industries, Inc.20231—
+11K230167BACK 4Swims America Corp20230—
+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—
+11K223292TempSure SystemCynosure, LLC20220—
+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—
+12K233962ReBorn (1050nm)Lightfective, Ltd.20240—
+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—
+13K2406581060nm laser body slimming machineHebei JT Medical Co., Ltd.20240—
+13K231971Deka Physiq 360El.En S.P.A.20230—
+13K182741SculpSureCynosure20195—
+13K172144CoolSculpting SystemZeltiq Aesthetics20177—
+14K231131Diode Laser Body Sculpture SystemsShanghai Bele Medical Technology Co.,Ltd20230—
+14K181740ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201805