510(k) Report

Devices descending from K031488

142 later devices reach Cynosure Apogee-TKS II Dermatological Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+6K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+6K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+6K22079410PLTentech Co., Ltd.20220—
+6K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+6K212790XLase PlusBiotec Italia, Srl20220—
+6K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+6K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+6K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+6K200736Stardust MedI.T.S. Group S.R.L.20200—
+6K200616E>EyeCE-Swin20200—
+6K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+6K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+6K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+6K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+6K171227StarWalkerFotona D.O.O.20177—
+6K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+7K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+7K241600DermablateAsclepion Laser Technologies GmbH20240—
+7K231054V-LaserWontech Co., Ltd.20231—
+7K223540AvalancheLase FamilyFotona D.O.O.20230—
+7K213267Dynamis Pro FamilyFotona D.O.O.20222—
+7K213350mJOULE System and AccessoriesSciton, Inc20220—
+7K202288FinebeamSNJ Co., Ltd.20212—
+7K203788DermaV Laser SystemLutronic Corporation202101
+7K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+7K202172StarWalkerFotona D.O.O.20203—
+7K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+7K183156V-LaserWontech Co., Ltd.20193—
+7K181518Sebacia MicroparticlesSebacia, Inc.20180—
+7K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+8K252723Dynamis Pro FamilyFotona D.O.O.20260—
+8K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+8K253342PICO-KSpeclipse, Inc.20251—
+8K253344Bellus-QSpeclipse, Inc.20250—
+8K251094Alma VeilWontech Co., Ltd.20250—
+8K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+8K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+8K221427V-LaserWontech Co., Ltd.20222—
+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—