510(k) Report

Devices descending from K170626

24 later devices reach Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+1K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+2K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+2K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+2K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+2K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+2K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+2K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+2K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+3K242859VEGAIbramed Equipamentos Médicos20250—
+3K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+3K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+3K241656Eneka SelectifTermosalud20241—
+3K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+3K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+3K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+3K230308Alma HarmonyAlma Lasers, Inc.20232—
+3K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+4K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+4K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+4K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+4K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+4K233024Alma HarmonyAlma Lasers, Inc.20241—
+5K252561BTL-754FFBTL Industries, Inc.20260—