510(k) Report

Devices descending from K110754

6 later devices reach Cryopen Cryosurgical System, K102214 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161480R2 Dermal Cooling SystemR2 Dermatology20165—
+2K171398Dermal Cooling SystemR2 Dermatology,Inc20174—
+3K201260Dermal Cooling SystemR2 Technologies, Inc.20203—
+4K203006R2 Dermabrasion Tip (for Dermal Cooling System)R2 Technologies, Inc.20212—
+5K213294Dermal Cooling SystemR2 Technologies, Inc.20221—
+6K253261Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—