510(k) Report

Devices descending from K072106

229 later devices reach 150W Ceralas D 980NM Diode Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K253965CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight…Wuhan PHOMED Technology Company, Ltd.20260—
+7K253342PICO-KSpeclipse, Inc.20251—
+7K253344Bellus-QSpeclipse, Inc.20250—
+7K251632Optimas MAX SystemInMode, Ltd.20251—
+7K251094Alma VeilWontech Co., Ltd.20250—
+7K241643WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)Wontech Co., Ltd.20252—
+7K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+7K242941CO2 Laser Therapy Systems (SHE-LSP003-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+7K243147LGO-Surgical Laser FibersLight Guide Optics International, Ltd.20241—
+7K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+7K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+7K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+7K232769BeaMed Laser Surgery FibersBt Beamedical Tachnoogies Ltd. (Beamed)20231—
+7K230819OmniGuide RFID Surgical Laser FibersOmni-Guide Holdings, Inc.20230—
+7K22079410PLTentech Co., Ltd.20220—
+7K221427V-LaserWontech Co., Ltd.20222—
+7K212790XLase PlusBiotec Italia, Srl20220—
+7K220793InnoVoyce Laser FiberInnovoyce, LLC20220—
+7K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+7K200736Stardust MedI.T.S. Group S.R.L.20200—
+7K200616E>EyeCE-Swin20200—
+7K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+7K161403A.R.C. Laser Surgical Fibers and ProbesA.R.C Laser GmbH20160—
+8K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+8K252745Halo Sterile Single-use Radial Fiber…Micro-Energy Medical Technology Co., Ltd.20251—
+8K253007Laser 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—
+8K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+8K250113neoLaser Laser Surgery FibersG.N.S Neolaser, Ltd.20250—
+9K261701Hemolase 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—