510(k) Report

Devices descending from K913758

131 later devices reach KTP/532 and KTP/Yag through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K222221Deka HelixEl.En Electronic Engineering Spa20231—
+8K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+8K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+8K203728DarwinLuvo Medical Technologies, Inc.20211—
+8K191855EmFace DeviceInmode MD, Ltd.20191—
+8K181095RF-ReliefEl Global Trade, Ltd.20181—
+8K172302InMode PLUS SystemInmode MD, Ltd.201713—
+8K162781Magma SparkFormatk Systems, Ltd.20160—
+9K252723Dynamis Pro FamilyFotona D.O.O.20260—
+9K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+9K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+9K250734OptiLUV DevicePollogen, Ltd.20250—
+9K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+9K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.20251—
+9K243139Reverso Pro SystemIndiba S. A. U.20250—
+9K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+9K242349FoLixLumenis Be, Ltd.20240—
+9K221571InMode Multi-systemInMode, Ltd.20222—
+9K212607DarwinLuvo Medical Technologies, Inc.20210—
+9K183450EmBody SystemInmode MD, Ltd.20198—
+10K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.20250—
+10K251632Optimas MAX SystemInMode, Ltd.20251—
+10K240991eMVFit (MVF-10M)Weero Co., Ltd.20240—
+10K210877Evolve System with the T3 ApplicatorInMode, Ltd.20215—
+10K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd.20216—
+11K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+11K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+11K241433EVE Synergy (EVE-20M)Weero Co., Ltd.20251—
+11K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+11K230167BACK 4Swims America Corp20230—
+11K230037BACK 3Swims America Corp20230—