510(k) Report

Devices descending from K981447

147 later devices reach Dio-Light 60 Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K163197Cook Holmium Laser FiberCook Incorporated20170—
+8K160513Quanta System Surgical Laser fibersQuanta System Spa201631
+8K152417Adler MicroMed Laser Surgery FibersAdler Micromed, Inc.20153—
+8K120023Zeltiq CoolsculptingZeltiq Aesthetics, Inc.201231—
+9K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.20260—
+9K241643WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)Wontech Co., Ltd.20252—
+9K243147LGO-Surgical Laser FibersLight Guide Optics International, Ltd.20241—
+9K232769BeaMed Laser Surgery FibersBt Beamedical Tachnoogies Ltd. (Beamed)20231—
+9K230819OmniGuide RFID Surgical Laser FibersOmni-Guide Holdings, Inc.20230—
+9K220793InnoVoyce Laser FiberInnovoyce, LLC20220—
+9K201387Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc.20210—
+9K161403A.R.C. Laser Surgical Fibers and ProbesA.R.C Laser GmbH20160—
+9K151179ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201526—
+9K142491ZEL TIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201527—
+9K133212Zeltiq Coolsculpting SystemZeltiq Aesthetics, Inc.201430—
+10K252745Halo Sterile Single-use Radial Fiber…Micro-Energy Medical Technology Co., Ltd.20251—
+10K253007Laser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); Laser Fiber (PT-OF-C-S); Laser Fiber…Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.20250—
+10K250113neoLaser Laser Surgery FibersG.N.S Neolaser, Ltd.20250—
+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—
+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—
+13K233099GladiatorRohrer Aesthetics, LLC20240—
+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—
+14K231131Diode Laser Body Sculpture SystemsShanghai Bele Medical Technology Co.,Ltd20230—
+14K181740ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201805