510(k) Report

Devices descending from K030147

323 later devices reach Lumenis Family of Ultrapulse Surgitouch CO2 Surgical Lasers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K253344Bellus-QSpeclipse, Inc.20250—
+9K252367InbellaMulti SystemInbella Medical, Inc.20250—
+9K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+9K251094Alma VeilWontech Co., Ltd.20250—
+9K242469RFMagik LiteAgnes Medical Co., Ltd.20252—
+9K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.20251—
+9K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+9K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+9K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+9K242349FoLixLumenis Be, Ltd.20240—
+9K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+9K233642InMode RF SystemInMode, Ltd.20244—
+9K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+9K221427V-LaserWontech Co., Ltd.20222—
+9K200736Stardust MedI.T.S. Group S.R.L.20200—
+9K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+10K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+10K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+10K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.20250—
+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—