510(k) Report

Devices descending from K133319

24 later devices reach ET Lightsheer 1060, High Speed Lightsheer 1060 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232117Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)Wuhan Lotuxs Technology Co., Ltd.20231—
+1K173677InMode VLazeInmode MD, Ltd.20183—
+1K170179LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer InfinityLumenis, Ltd.201714—
+1K141555AdvantageLutronic Corporation201414—
+2K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+2K231910DermRays ReviveWuhan Lotuxs Technology Co., Ltd.20240—
+2K232236EchoQuanta System Spa20230—
+2K221571InMode Multi-systemInMode, Ltd.20222—
+2K213261EpilMENeauvia North America20220—
+2K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+2K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+2K193367elysion-proHigh Technology Products S.L.U20203—
+2K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+2K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+3K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+3K251632Optimas MAX SystemInMode, Ltd.20251—
+3K241656Eneka SelectifTermosalud20241—
+3K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+3K234057NirvanaEl.En S.P.A.20240—
+3K223680Eneka ProTermosalud20230—
+3K222369PURE LaserEndymed Medical, Ltd.20220—
+3K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+4K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+4K252215InbellaMAX SystemInbella Medical, Ltd.20250—