510(k) Report

Devices descending from K024189

328 later devices reach Nlite System, Model#: A00-1025/A00-1033 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+10K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+10K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+10K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa201918—
+10K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+10K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+10K153566Magma SystemFormatk Systems, Ltd.20162—
+11K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—
+11K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+11K250809Stellar M22Lumenis Be, Ltd.20250—
+11K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+11K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+11K222790F65 Laser SystemLumenis Be, Ltd.20233—
+11K222221Deka HelixEl.En Electronic Engineering Spa20231—
+11K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+11K202503ChromeQuanta System Spa202012—
+11K162781Magma SparkFormatk Systems, Ltd.20160—
+12K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+12K253765Vanish ProDdc Technologies, Inc.20260—
+12K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+12K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.20251—
+12K241527Pastelle ProWontech Co., Ltd.20253—
+12K242349FoLixLumenis Be, Ltd.20240—
+12K223404Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4VQuanta System Spa20230—
+12K213726PL-1 Skin Treatment SystemAVAVA, Inc.20220—
+12K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+13K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.20250—
+13K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical Incorporated20250—