510(k) Report

Devices descending from K182392

6 later devices reach Frozen C through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201260Dermal Cooling SystemR2 Technologies, Inc.20203—
+1K193665Frozen NYozma Bmtech Co., Ltd.20201—
+2K203661CRYO Arctic, CRYO PenguinCryoscience North America, Inc.20220—
+2K203006R2 Dermabrasion Tip (for Dermal Cooling System)R2 Technologies, Inc.20212—
+3K213294Dermal Cooling SystemR2 Technologies, Inc.20221—
+4K253261Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—