510(k) Report

Devices descending from K082819

10 later devices reach Dermatologic Treatment System (DTS) G2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181941Swift SystemEmblation, Ltd.20183—
+1K103014Miradry SystemMiramar Labs, Inc.201152
+2K250718swiftPro System (SWF-SPS); Swift System (SWF-SYS)Emblation Limited20250—
+2K222388swiftPro SystemEmblation, Ltd.20232—
+2K141511SIDELAZE800 Laser Beam Delivery Accessory for Cynosure 1440MM Wavelength LasersCynosure, Inc.20150—
+2K131162Miradry SystemMiramar Labs, Inc.201331
+3K240518swiftPro™ SystemEmblation Limited20241—
+3K150419miraDry System MD4000Miramar Labs, Inc.201521
+4K160141miraDry SystemMiramar Labs, Inc.20161—
+5K180396miraDry SystemMiramar Labs, Inc.20180—