510(k) Report

Devices descending from K982940

1,526 later devices reach Lightsheer Pulsed Diode Array Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K182741SculpSureCynosure20195—
+11K172771Epic Pro 940Biolase, Inc.20171—
+11K161403A.R.C. Laser Surgical Fibers and ProbesA.R.C Laser GmbH20160—
+11K160259ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201615—
+12K260307Diode Laser Therapy Systems (V19)Weifang Mingliang Electronics Co., Ltd.20260—
+12K260765Gemini NOVA 810+980 Soft Tissue LaserAzena Medical, LLC20260—
+12K252745Halo Sterile Single-use Radial Fiber…Micro-Energy Medical Technology Co., Ltd.20251—
+12K253007Laser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); Laser Fiber (PT-OF-C-S); Laser Fiber…Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.20250—
+12K251801Diode laser device (BM091)Hebei Newangie Technology Co., Ltd.20250—
+12K250431Medical Diode Laser Hair Removal System (MNLT-D1)Shandong Moonlight Electronics Tech Co., Ltd.20251—
+12K250113neoLaser Laser Surgery FibersG.N.S Neolaser, Ltd.20250—
+12K243465Diode Laser Hair Removal Device (EVOLUTION MEDICAL); Diode Laser Hair Removal Device…Guangzhou Chuang Zao Mei Technology Co., Ltd.20250—
+12K243737Inbella RF SystemInbella Medical, Inc.20250—
+12K241498Diode laser Treatment System (K18)Hebei Keylaser Sci-Tech Co.,Ltd20240—
+12K230467BTL-899FBTL Industries, Inc.20231—
+12K231131Diode Laser Body Sculpture SystemsShanghai Bele Medical Technology Co.,Ltd20230—
+12K230124LUSTRE ClearSkin Renew Pro Facewear Mask (Model: PR4001)Light Tree Ventures Europe B.V.202310—
+12K223404Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4VQuanta System Spa20230—
+12K223292TempSure SystemCynosure, LLC20220—
+12K213726PL-1 Skin Treatment SystemAVAVA, Inc.20220—
+12K162050ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201614—
+13K261701Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8)Micro-Energy Medical Technology Co., Ltd.20260—
+13K252048808nm semiconductor laser hair removal machineXi'An Taibo Electronic Technology Co., Ltd.20260—
+13K171069ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.20178—
+14K172144CoolSculpting SystemZeltiq Aesthetics20177—
+15K181740ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201805