510(k) Report

Devices descending from K083215

136 later devices reach Incisive Family of Inpulse ND:Yag Lasers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K242859VEGAIbramed Equipamentos Médicos20250—
+7K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+7K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+7K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+7K241656Eneka SelectifTermosalud20241—
+7K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+7K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+7K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+7K230308Alma HarmonyAlma Lasers, Inc.20232—
+7K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+7K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+7K191855EmFace DeviceInmode MD, Ltd.20191—
+7K181095RF-ReliefEl Global Trade, Ltd.20181—
+7K172302InMode PLUS SystemInmode MD, Ltd.201713—
+8K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+8K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+8K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+8K250734OptiLUV DevicePollogen, Ltd.20250—
+8K243139Reverso Pro SystemIndiba S. A. U.20250—
+8K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+8K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+8K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+8K233024Alma HarmonyAlma Lasers, Inc.20241—
+8K221571InMode Multi-systemInMode, Ltd.20222—
+8K183450EmBody SystemInmode MD, Ltd.20198—
+9K252561BTL-754FFBTL Industries, Inc.20260—
+9K251632Optimas MAX SystemInMode, Ltd.20251—
+9K240991eMVFit (MVF-10M)Weero Co., Ltd.20240—
+9K210877Evolve System with the T3 ApplicatorInMode, Ltd.20215—
+9K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd.20216—
+10K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+10K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+10K241433EVE Synergy (EVE-20M)Weero Co., Ltd.20251—
+10K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+10K230167BACK 4Swims America Corp20230—
+10K230037BACK 3Swims America Corp20230—