510(k) Report

Devices descending from K950661

1,153 later devices reach Candela 10MM Circular Spot Laser Handpiece through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K180044SIROLaser BlueDentsply Sirona201812—
+11K163128Epic ProBiolase, Inc.201716—
+11K160470SculpSureCynosure, Inc.201620—
+11K160259ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201615—
+11K150724SculpSureCynosure, Inc.201521—
+11K150230SculpSureCynosure, Inc.201521—
+11K122020Photon Photon PlusZolar Technology & Mfg Co., Inc.20134—
+12K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+12K250731MateLaser Medical Diode Laser Systems (ML-DLS-30)Matelaser, Inc.20250—
+12K250217AGNES UltraAgnes Medical Co., Ltd.20250—
+12K243713Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A…Agnes Medical Co., Ltd.20250—
+12K241433EVE Synergy (EVE-20M)Weero Co., Ltd.20251—
+12K243764Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)Wuhan Pioon Technology Co., Ltd.20250—
+12K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+12K240780InMode RF SystemInMode, Ltd.20243—
+12K234085LUNE™ PureHygieneEnamel Pure20241—
+12K230047Medical Diode Laser SystemsGigaalaser Company, Ltd.20242—
+12K230167BACK 4Swims America Corp20230—
+12K230037BACK 3Swims America Corp20230—
+12K230124LUSTRE ClearSkin Renew Pro Facewear Mask (Model: PR4001)Light Tree Ventures Europe B.V.202310—
+12K223404Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4VQuanta System Spa20230—
+12K213726PL-1 Skin Treatment SystemAVAVA, Inc.20220—
+12K211681EONDominion Aesthetic Technologies, Inc.20221—
+12K210350Gemini 2 810+980 Soft Tissue LaserAzena Medical, LLC20211—
+12K201387Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc.20210—
+12K191068Powersculp laser lipolysis systemWuhan Lotuxs Technology Co., Ltd.20196—
+12K190743Venus BlissVenus Concept USA, Inc.20194—
+12K172771Epic Pro 940Biolase, Inc.20171—
+12K171111SculpsureCynosure, Inc.201710—
+12K162050ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201614—
+13K260138LUNE PureHygieneEnamel Pure20260—
+13K260765Gemini NOVA 810+980 Soft Tissue LaserAzena Medical, LLC20260—
+13K242755Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE…Gigaalaser Company, Ltd.20251—
+13K243737Inbella RF SystemInbella Medical, Inc.20250—
+13K233962ReBorn (1050nm)Lightfective, Ltd.20240—
+13K222226EONDominion Aesthetic Technologies, Inc.20230—
+13K222265DiosculptShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20220—
+13K213308Venus BlissMAXVenus Concept USA, Inc.20222—
+13K212331BodySculpRohrer Aesthetics, LLC20211—
+13K211402Powersculp laser lipolysis systemLotuxs Medtech (Suzhou) Co., Ltd.20210—
+13K192970SlimusHironic Co., Ltd.20200—
+13K201731Diode Laser Body Sculpture SystemShanghai Apolo Medical Technology Co., Ltd.20201—
+13K171992SculpSureCynosure, Inc.20178—
+13K171069ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.20178—
+14K253965CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight…Wuhan PHOMED Technology Company, Ltd.20260—
+14K2406581060nm laser body slimming machineHebei JT Medical Co., Ltd.20240—
+14K231971Deka Physiq 360El.En S.P.A.20230—
+14K220592Venus BlissMAXVenus Concept USA, Inc.20221—
+14K182741SculpSureCynosure20195—
+14K172144CoolSculpting SystemZeltiq Aesthetics20177—
+15K252845Venus Nova (FP-2001)Venus Concept, Inc.20250—
+15K231131Diode Laser Body Sculpture SystemsShanghai Bele Medical Technology Co.,Ltd20230—
+15K181740ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201805