510(k) Report

Devices descending from K042474

114 later devices reach ARION through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K181518Sebacia MicroparticlesSebacia, Inc.20180—
+6K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+7K252723Dynamis Pro FamilyFotona D.O.O.20260—
+7K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+7K253342PICO-KSpeclipse, Inc.20251—
+7K253344Bellus-QSpeclipse, Inc.20250—
+7K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+7K251094Alma VeilWontech Co., Ltd.20250—
+7K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+7K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+7K221427V-LaserWontech Co., Ltd.20222—
+7K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+8K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+8K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—