510(k) Report

Devices descending from K060310

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+7K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+7K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+7K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+7K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+7K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+7K173359Fractional CO2 Surgical Laser SystemAmi, Inc.20180—
+7K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+7K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+7K153566Magma SystemFormatk Systems, Ltd.20162—
+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—
+8K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—
+8K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+8K250809Stellar M22Lumenis Be, Ltd.20250—
+8K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+8K233123SilkroHironic Co., Ltd.20241—
+8K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—
+8K233099GladiatorRohrer Aesthetics, LLC20240—
+8K233143PiXel8-RevealRohrer Aesthetics20240—
+8K233147PiXel8-RFRohrer Aesthetics20230—
+8K222790F65 Laser SystemLumenis Be, Ltd.20233—
+8K222221Deka HelixEl.En Electronic Engineering Spa20231—
+8K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+8K211000AcutronIlooda Co,., Ltd.20220—
+8K162781Magma SparkFormatk Systems, Ltd.20160—
+9K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+9K251334New Doublo 2.0Hironic Co., Ltd.20250—
+9K242349FoLixLumenis Be, Ltd.20240—