510(k) Report

Devices descending from K102541

39 later devices reach Cynosure Cellulaze Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201801Rapid Acoustic Pulse DeviceSoliton, Inc.202112—
+1K121127Sidelaze Laser Beam Delivery Accessory for Cynosure 1440NM Wavelength LasersCynosure, Inc.201225—
+2K223237SofWave SystemSofwave Medical, Ltd.20227—
+2K210964Resonic Rapid Acoustic Pulse DeviceSoliton, Inc.20213—
+2K141511SIDELAZE800 Laser Beam Delivery Accessory for Cynosure 1440MM Wavelength LasersCynosure, Inc.20150—
+2K131473(Quanta System) Surgical Laser FibersQuanta System Spa201351
+2K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+3K230019SofWave SystemSofwave Medical, Ltd.20236—
+3K212502Resonic Rapid Acoustic Pulse DeviceSoliton, Inc.20212—
+3K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+3K163197Cook Holmium Laser FiberCook Incorporated20170—
+3K160513Quanta System Surgical Laser fibersQuanta System Spa201631
+3K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies20145—
+4K250776Lithoblast Single Use Holmium Laser FibersDawell Medical, LLC20250—
+4K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC20240—
+4K232106Air Gap FiberWontech Co., Ltd.20240—
+4K230820SofWave SystemSofwave Medical, Ltd.20235—
+4K222629Resonic Rapid Acoustic Pulse DeviceZeltiq Aesthetics, Inc.20221—
+4K220189LISA Laser Surgical FibersOmni-Guide Holdings, Inc.20225—
+4K201171LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe DisposableLeoni Fiber Optics, Inc.20210—
+4K200234Surgical laser fibersQuanta System Spa20202—
+4K151855SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral…Surgical Laser Incorporated20160—
+4K152417Adler MicroMed Laser Surgery FibersAdler Micromed, Inc.20153—
+5K241643WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)Wontech Co., Ltd.20252—
+5K243147LGO-Surgical Laser FibersLight Guide Optics International, Ltd.20241—
+5K233804Resonic Rapid Acoustic Pulse DeviceZeltiq Aesthetics, Inc.20240—
+5K232455SofWave SystemSofwave Medical, Ltd.20234—
+5K232769BeaMed Laser Surgery FibersBt Beamedical Tachnoogies Ltd. (Beamed)20231—
+5K230819OmniGuide RFID Surgical Laser FibersOmni-Guide Holdings, Inc.20230—
+5K220793InnoVoyce Laser FiberInnovoyce, LLC20220—
+5K161403A.R.C. Laser Surgical Fibers and ProbesA.R.C Laser GmbH20160—
+6K252745Halo Sterile Single-use Radial Fiber…Micro-Energy Medical Technology Co., Ltd.20251—
+6K253007Laser 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—
+6K250113neoLaser Laser Surgery FibersG.N.S Neolaser, Ltd.20250—
+6K240687SofWave SystemSofwave Medical, Ltd.20243—
+7K261701Hemolase 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—
+7K241685SofWave SystemSofwave Medical, Ltd.20242—
+8K250146SofWave SystemSofwave Medical, Ltd.20251—
+9K251746Pure ImpactSofwave Medical, Ltd.20250—