510(k) Report

Devices descending from K023954

1,117 later devices reach Altus Medical Coolglide Laser Systems and Accessories through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K243737Inbella RF SystemInbella Medical, Inc.20250—
+10K243040LED Light Therapy Mask…Shenzhen Siken 3D Technology Development Co., Ltd.20241—
+10K241498Diode laser Treatment System (K18)Hebei Keylaser Sci-Tech Co.,Ltd20240—
+10K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+10K230467BTL-899FBTL Industries, Inc.20231—
+10K230167BACK 4Swims America Corp20230—
+10K230037BACK 3Swims America Corp20230—
+10K231131Diode Laser Body Sculpture SystemsShanghai Bele Medical Technology Co.,Ltd20230—
+10K223404Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4VQuanta System Spa20230—
+10K223292TempSure SystemCynosure, LLC20220—
+10K213726PL-1 Skin Treatment SystemAVAVA, Inc.20220—
+10K162050ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201614—
+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—
+11K252048808nm semiconductor laser hair removal machineXi'An Taibo Electronic Technology Co., Ltd.20260—
+11K171069ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.20178—
+12K172144CoolSculpting SystemZeltiq Aesthetics20177—
+13K181740ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201805