510(k) Report

Devices descending from K990119

50 later devices reach Epi-Star Surgical Laser Syster through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K013864Modification to Epi-Star Surgical Laser System, M0DEL DS-60Nidek, Inc.200249—
+2K040727CRYO 5Zimmer Elektromedizin GmbH200448—
+3K090618Cynosure Smartcool Family Cold Air Device: Smartcool, Smartcool 6 and Cryo CCynosure, Inc.20090—
+3K060407Juniper Cooling DeviceJuniper Medical Technology, Inc.200636—
+3K052310Cryoflow 700, Cryoflow 1000Uniphy Elektromedizin GmbH & Co. KG20060—
+3K060395Cryo, Model V6.0Zimmer Elektromedizin GmbH20069—
+4K242132FreddoFabinject Lndustria E Comercio Lmportacao E Exportacao Ltda20240—
+4K220020Cryo 7Zimmer Medizinsysteme GmbH20222—
+4K083008CoolskinElbio Co., Ltd.20092—
+4K080735CryominiZimmer Elektromedizin GmbH20081—
+4K072152Juniper CLN1 Dermal Cooling DeviceJuniper Medical, Inc.200734—
+4K063715Juniper Cooling Device XtraJuniper Medical, Inc.200735—
+5K261674Skin Air Cooling System (QALF-01)Beijing Nubway S&T Co., Ltd.20260—
+5K233416Cryojet Plus (SHE-ACP001-1)Beijing Sano Laser S&T Development Co.,Ltd20241—
+5K213294Dermal Cooling SystemR2 Technologies, Inc.20221—
+5K080118Zeltiq Aesthetics CLN1 Dermal Cooling DeviceZeltiq Aesthetics200833—
+6K253261Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+6K090094Zeltiq SystemZeltiq Aesthetics200932—
+7K120023Zeltiq CoolsculptingZeltiq Aesthetics, Inc.201231—
+8K151179ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201526—
+8K142491ZEL TIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201527—
+8K133212Zeltiq Coolsculpting SystemZeltiq Aesthetics, Inc.201430—
+9K160470SculpSureCynosure, Inc.201620—
+9K160259ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201615—
+9K150724SculpSureCynosure, Inc.201521—
+9K150230SculpSureCynosure, Inc.201521—
+10K211681EONDominion Aesthetic Technologies, Inc.20221—
+10K191068Powersculp laser lipolysis systemWuhan Lotuxs Technology Co., Ltd.20196—
+10K190743Venus BlissVenus Concept USA, Inc.20194—
+10K171111SculpsureCynosure, Inc.201710—
+10K162050ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201614—
+11K233962ReBorn (1050nm)Lightfective, Ltd.20240—
+11K222226EONDominion Aesthetic Technologies, Inc.20230—
+11K222265DiosculptShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20220—
+11K213308Venus BlissMAXVenus Concept USA, Inc.20222—
+11K212331BodySculpRohrer Aesthetics, LLC20211—
+11K211402Powersculp laser lipolysis systemLotuxs Medtech (Suzhou) Co., Ltd.20210—
+11K192970SlimusHironic Co., Ltd.20200—
+11K201731Diode Laser Body Sculpture SystemShanghai Apolo Medical Technology Co., Ltd.20201—
+11K171992SculpSureCynosure, Inc.20178—
+11K171069ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.20178—
+12K233099GladiatorRohrer Aesthetics, LLC20240—
+12K2406581060nm laser body slimming machineHebei JT Medical Co., Ltd.20240—
+12K231971Deka Physiq 360El.En S.P.A.20230—
+12K220592Venus BlissMAXVenus Concept USA, Inc.20221—
+12K182741SculpSureCynosure20195—
+12K172144CoolSculpting SystemZeltiq Aesthetics20177—
+13K252845Venus Nova (FP-2001)Venus Concept, Inc.20250—
+13K231131Diode Laser Body Sculpture SystemsShanghai Bele Medical Technology Co.,Ltd20230—
+13K181740ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201805