510(k) Report

Devices descending from K042319

284 later devices reach Reliant Laser II System and Accessories through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K233147PiXel8-RFRohrer Aesthetics20230—
+7K232236EchoQuanta System Spa20230—
+7K231054V-LaserWontech Co., Ltd.20231—
+7K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+7K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+7K222790F65 Laser SystemLumenis Be, Ltd.20233—
+7K222556BTL-785XBTL Industries, Inc.20235—
+7K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+7K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+7K223540AvalancheLase FamilyFotona D.O.O.20230—
+7K222221Deka HelixEl.En Electronic Engineering Spa20231—
+7K22079410PLTentech Co., Ltd.20220—
+7K221574LUDWIG Electrosurgical DeviceAesthetics Biomedical20220—
+7K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+7K213267Dynamis Pro FamilyFotona D.O.O.20222—
+7K212790XLase PlusBiotec Italia, Srl20220—
+7K211000AcutronIlooda Co,., Ltd.20220—
+7K213350mJOULE System and AccessoriesSciton, Inc20220—
+7K220124YandR System, VoluDerm Handpiece, VoluDerm TipsPollogen, Ltd.20220—
+7K202288FinebeamSNJ Co., Ltd.20212—
+7K212607DarwinLuvo Medical Technologies, Inc.20210—
+7K203788DermaV Laser SystemLutronic Corporation202101
+7K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+7K201685PotenzaJeisys Medical, Inc.20219—
+7K201735PlaDuo SystemShenB Co., Ltd.20203—
+7K202172StarWalkerFotona D.O.O.20203—
+7K200947InMode System with the Morhpeus8 ApplicatorsInMode, Ltd.202015—
+7K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+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—
+7K162781Magma SparkFormatk Systems, Ltd.20160—
+8K252723Dynamis Pro FamilyFotona D.O.O.20260—
+8K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+8K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+8K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+8K254290ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Shenzhen Peninsula Medical Group20260—
+8K253342PICO-KSpeclipse, Inc.20251—
+8K253344Bellus-QSpeclipse, Inc.20250—
+8K251334New Doublo 2.0Hironic Co., Ltd.20250—
+8K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+8K243176BLESSING SystemCellah Medical Co., Ltd.20251—
+8K251094Alma VeilWontech Co., Ltd.20250—
+8K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.20251—
+8K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+8K242688Finiff SystemSkingrab Co., Ltd.20240—
+8K231216PotenzaJeisys Medical, Inc.20244—
+8K231287PotenzaJeisys Medical, Inc.20241—
+8K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+8K242349FoLixLumenis Be, Ltd.20240—
+8K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+8K240999Legend X Applicator VOPollogen, Ltd.20241—
+8K233849BTL-499BTL Industries, Inc.20240—
+8K233604BTL-785SBTL Industries, Inc.20243—
+8K230837PlazMagikAgnes Medical Co., Ltd.20240—
+8K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+8K232223PlaDuo SystemShenB Co., Ltd.20230—
+8K231790The InMode System with the Morpheus8 ApplicatorsInMode, Ltd.202310—
+8K221427V-LaserWontech Co., Ltd.20222—
+8K212472AgeJetTriworks Group Srl20220—
+8K200736Stardust MedI.T.S. Group S.R.L.20200—
+8K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+9K254185Potenza PrimeJeisys Medical Incorporated20260—
+9K253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.20260—
+9K253484Lutronic GeniusCynosure Lutronic Technology Corporation20260—
+9K253803MILAN SystemLumenis Be, Ltd.20260—
+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—
+9K253750BTL-785NEHBTL Industries, Inc.20260—
+9K251435InbellaIgnite RF SystemInbella Medical, Inc.20260—
+9K251254Ignite RF SystemInMode, Ltd.20260—
+9K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.20250—
+9K252367InbellaMulti SystemInbella Medical, Inc.20250—
+9K242469RFMagik LiteAgnes Medical Co., Ltd.20252—
+9K242532BTL-785BNF-EBTL Industries, Inc.20241—
+9K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+9K233642InMode RF SystemInMode, Ltd.20244—
+10K260945Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension…Fit-Pro KFT (Ltd.) - DBA E-Fit20260—
+10K250217AGNES UltraAgnes Medical Co., Ltd.20250—
+10K243713Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A…Agnes Medical Co., Ltd.20250—
+10K240780InMode RF SystemInMode, Ltd.20243—
+11K243737Inbella RF SystemInbella Medical, Inc.20250—