510(k) Report

Devices descending from K103626

121 later devices reach Cutera Genesisplus Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+7K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+7K250734OptiLUV DevicePollogen, Ltd.20250—
+7K243139Reverso Pro SystemIndiba S. A. U.20250—
+7K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+7K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+7K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+7K233024Alma HarmonyAlma Lasers, Inc.20241—
+7K221571InMode Multi-systemInMode, Ltd.20222—
+7K183450EmBody SystemInmode MD, Ltd.20198—
+8K252561BTL-754FFBTL Industries, Inc.20260—
+8K251632Optimas MAX SystemInMode, Ltd.20251—
+8K240991eMVFit (MVF-10M)Weero Co., Ltd.20240—
+8K210877Evolve System with the T3 ApplicatorInMode, Ltd.20215—
+8K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd.20216—
+9K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+9K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+9K241433EVE Synergy (EVE-20M)Weero Co., Ltd.20251—
+9K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+9K230167BACK 4Swims America Corp20230—
+9K230037BACK 3Swims America Corp20230—