510(k) Report

Devices descending from K170060

24 later devices reach M22 and ResurFx Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+1K200616E>EyeCE-Swin20200—
+1K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+1K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+1K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+2K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—
+2K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+2K250809Stellar M22Lumenis Be, Ltd.20250—
+2K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+2K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+2K233024Alma HarmonyAlma Lasers, Inc.20241—
+2K222790F65 Laser SystemLumenis Be, Ltd.20233—
+2K222221Deka HelixEl.En Electronic Engineering Spa20231—
+2K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+2K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+3K252723Dynamis Pro FamilyFotona D.O.O.20260—
+3K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+3K252561BTL-754FFBTL Industries, Inc.20260—
+3K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+3K242349FoLixLumenis Be, Ltd.20240—
+3K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+4K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+5K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.20251—
+6K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.20250—