510(k) Report

Devices descending from K102755

46 later devices reach Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+1K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc.201126—
+2K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+2K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+2K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—
+2K112442Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20110—
+3K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+3K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—
+3K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+3K233344Regenalase Laser SystemIpg Medical20240—
+3K193656SkyPulseFotona D.O.O.202011—
+3K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+3K151855SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral…Surgical Laser Incorporated20160—
+3K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies20145—
+3K131473(Quanta System) Surgical Laser FibersQuanta System Spa201351
+4K250776Lithoblast Single Use Holmium Laser FibersDawell Medical, LLC20250—
+4K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+4K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+4K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+4K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+4K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC20240—
+4K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+4K232106Air Gap FiberWontech Co., Ltd.20240—
+4K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+4K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+4K220189LISA Laser Surgical FibersOmni-Guide Holdings, Inc.20225—
+4K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+4K201171LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe DisposableLeoni Fiber Optics, Inc.20210—
+4K200234Surgical laser fibersQuanta System Spa20202—
+4K163197Cook Holmium Laser FiberCook Incorporated20170—
+4K160513Quanta System Surgical Laser fibersQuanta System Spa201631
+4K152417Adler MicroMed Laser Surgery FibersAdler Micromed, Inc.20153—
+5K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+5K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+5K241643WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)Wontech Co., Ltd.20252—
+5K243147LGO-Surgical Laser FibersLight Guide Optics International, Ltd.20241—
+5K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+5K232769BeaMed Laser Surgery FibersBt Beamedical Tachnoogies Ltd. (Beamed)20231—
+5K230819OmniGuide RFID Surgical Laser FibersOmni-Guide Holdings, Inc.20230—
+5K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+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—
+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—