510(k) Report

Devices descending from K043046

321 later devices reach Cooltouch, Model CT3S through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K161403A.R.C. Laser Surgical Fibers and ProbesA.R.C Laser GmbH20160—
+9K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+9K153566Magma SystemFormatk Systems, Ltd.20162—
+10K252745Halo Sterile Single-use Radial Fiber…Micro-Energy Medical Technology Co., Ltd.20251—
+10K253007Laser 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—
+10K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—
+10K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+10K250809Stellar M22Lumenis Be, Ltd.20250—
+10K250113neoLaser Laser Surgery FibersG.N.S Neolaser, Ltd.20250—
+10K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+10K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+10K222790F65 Laser SystemLumenis Be, Ltd.20233—
+10K222221Deka HelixEl.En Electronic Engineering Spa20231—
+10K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+10K162781Magma SparkFormatk Systems, Ltd.20160—
+11K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+11K261701Hemolase 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—
+11K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+11K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.20251—
+11K242349FoLixLumenis Be, Ltd.20240—
+12K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.20250—