510(k) Report

Devices descending from K993911

156 later devices reach Ceralas D Diode Laser System, Model D15, D25,D50 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K242859VEGAIbramed Equipamentos Médicos20250—
+7K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+7K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+7K241656Eneka SelectifTermosalud20241—
+7K241600DermablateAsclepion Laser Technologies GmbH20240—
+7K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+7K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+7K234057NirvanaEl.En S.P.A.20240—
+7K233024Alma HarmonyAlma Lasers, Inc.20241—
+7K232222Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)Medency S.R.L.20230—
+7K232236EchoQuanta System Spa20230—
+7K231054V-LaserWontech Co., Ltd.20231—
+7K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+7K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+7K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+7K223540AvalancheLase FamilyFotona D.O.O.20230—
+7K213267Dynamis Pro FamilyFotona D.O.O.20222—
+7K221571InMode Multi-systemInMode, Ltd.20222—
+7K213350mJOULE System and AccessoriesSciton, Inc20220—
+7K202288FinebeamSNJ Co., Ltd.20212—
+7K212607DarwinLuvo Medical Technologies, Inc.20210—
+7K203788DermaV Laser SystemLutronic Corporation202101
+7K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+7K200693K2 MobileHulaser, Inc.20202—
+7K202172StarWalkerFotona D.O.O.20203—
+7K192856MT OneM&T S.R.L.20202—
+7K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+7K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+7K191942MT One DiamondM&T S.R.L.20191—
+7K183156V-LaserWontech Co., Ltd.20193—
+7K181518Sebacia MicroparticlesSebacia, Inc.20180—
+7K172413MT ONEM&T S.R.L.20175—
+7K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+8K252723Dynamis Pro FamilyFotona D.O.O.20260—
+8K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.20260—
+8K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+8K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+8K253342PICO-KSpeclipse, Inc.20251—
+8K253344Bellus-QSpeclipse, Inc.20250—
+8K251632Optimas MAX SystemInMode, Ltd.20251—
+8K251094Alma VeilWontech Co., Ltd.20250—
+8K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+8K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+8K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+8K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+8K22079410PLTentech Co., Ltd.20220—
+8K221427V-LaserWontech Co., Ltd.20222—
+8K212790XLase PlusBiotec Italia, Srl20220—
+8K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+8K201387Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc.20210—
+8K200736Stardust MedI.T.S. Group S.R.L.20200—
+8K200616E>EyeCE-Swin20200—
+8K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+9K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+9K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+9K252215InbellaMAX SystemInbella Medical, Ltd.20250—