510(k) Report

Devices descending from K050738

225 later devices reach FT Fiber Optic Delivery Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K253344Bellus-QSpeclipse, Inc.20250—
+7K253100MultiPulse TFLAsclepion Laser Technologies GmbH20251—
+7K251632Optimas MAX SystemInMode, Ltd.20251—
+7K250465CO2 Laser Machine (Lume)Nanjing Bestview Laser S&T Co., Ltd.20250—
+7K251094Alma VeilWontech Co., Ltd.20250—
+7K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+7K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+7K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+7K232133Co2 Laser System, Models: PureLase And VanLaseCpmt Laser (Canadian Pioneer Medical Technology Corporation)20240—
+7K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+7K22079410PLTentech Co., Ltd.20220—
+7K221597CO2 Laser SystemSmedtrum Medical Technology Co., Ltd.20222—
+7K221427V-LaserWontech Co., Ltd.20222—
+7K212790XLase PlusBiotec Italia, Srl20220—
+7K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+7K202041Opera EvoQuanta System Spa20200—
+7K200736Stardust MedI.T.S. Group S.R.L.20200—
+7K200616E>EyeCE-Swin20200—
+7K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+7K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+8K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+8K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+8K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+8K241670Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System…Beijing Adss Development Co., Ltd.20241—
+9K242941CO2 Laser Therapy Systems (SHE-LSP003-1)Beijing Sano Laser S&T Development Co.,Ltd20250—