510(k) Report

Devices descending from K062303

226 later devices reach Fraxel II SR Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+7K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+7K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+7K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+7K233123SilkroHironic Co., Ltd.20241—
+7K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—
+7K233099GladiatorRohrer Aesthetics, LLC20240—
+7K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+7K233143PiXel8-RevealRohrer Aesthetics20240—
+7K233147PiXel8-RFRohrer Aesthetics20230—
+7K222790F65 Laser SystemLumenis Be, Ltd.20233—
+7K222221Deka HelixEl.En Electronic Engineering Spa20231—
+7K22079410PLTentech Co., Ltd.20220—
+7K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+7K221427V-LaserWontech Co., Ltd.20222—
+7K212790XLase PlusBiotec Italia, Srl20220—
+7K211000AcutronIlooda Co,., Ltd.20220—
+7K200736Stardust MedI.T.S. Group S.R.L.20200—
+7K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+7K162781Magma SparkFormatk Systems, Ltd.20160—
+8K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+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—
+8K251334New Doublo 2.0Hironic Co., Ltd.20250—
+8K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+8K242349FoLixLumenis Be, Ltd.20240—