510(k) Report

Devices descending from K013365

1,127 later devices reach Prolite Pulsed Light System for the Treatment of Pigmented Lesions and the… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K260765Gemini NOVA 810+980 Soft Tissue LaserAzena Medical, LLC20260—
+11K253135LED Light Therapy Device (HLGMZ-3W-G1V1,HLGMZ-3W-G2V1,HLG-GJXJ-G1V1,HGMZ-2W-G1V1…Dongguan Yijiaming Technology Co., Ltd.20250—
+11K252745Halo Sterile Single-use Radial Fiber…Micro-Energy Medical Technology Co., Ltd.20251—
+11K253007Laser 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—
+11K251801Diode laser device (BM091)Hebei Newangie Technology Co., Ltd.20250—
+11K241433EVE Synergy (EVE-20M)Weero Co., Ltd.20251—
+11K250431Medical Diode Laser Hair Removal System (MNLT-D1)Shandong Moonlight Electronics Tech Co., Ltd.20251—
+11K250113neoLaser Laser Surgery FibersG.N.S Neolaser, Ltd.20250—
+11K243465Diode Laser Hair Removal Device (EVOLUTION MEDICAL); Diode Laser Hair Removal Device…Guangzhou Chuang Zao Mei Technology Co., Ltd.20250—
+11K242941CO2 Laser Therapy Systems (SHE-LSP003-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+11K243737Inbella RF SystemInbella Medical, Inc.20250—
+11K243040LED Light Therapy Mask…Shenzhen Siken 3D Technology Development Co., Ltd.20241—
+11K241498Diode laser Treatment System (K18)Hebei Keylaser Sci-Tech Co.,Ltd20240—
+11K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+11K230467BTL-899FBTL Industries, Inc.20231—
+11K230167BACK 4Swims America Corp20230—
+11K230037BACK 3Swims America Corp20230—
+11K231131Diode Laser Body Sculpture SystemsShanghai Bele Medical Technology Co.,Ltd20230—
+11K223404Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4VQuanta System Spa20230—
+11K223292TempSure SystemCynosure, LLC20220—
+11K213726PL-1 Skin Treatment SystemAVAVA, Inc.20220—
+11K162050ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201614—
+12K261701Hemolase 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—
+12K252048808nm semiconductor laser hair removal machineXi'An Taibo Electronic Technology Co., Ltd.20260—
+12K171069ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.20178—
+13K172144CoolSculpting SystemZeltiq Aesthetics20177—
+14K181740ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201805