510(k) Report

Devices descending from K161480

5 later devices reach R2 Dermal Cooling System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171398Dermal Cooling SystemR2 Dermatology,Inc20174—
+2K201260Dermal Cooling SystemR2 Technologies, Inc.20203—
+3K203006R2 Dermabrasion Tip (for Dermal Cooling System)R2 Technologies, Inc.20212—
+4K213294Dermal Cooling SystemR2 Technologies, Inc.20221—
+5K253261Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—