510(k) Report

Devices descending from K803311

8 later devices reach LL100 Cryosurgical System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110754Cryopen Cryosurgical System, K102214Cryopen, Inc.20116—
+1K012214Cryopen and AccessoriesCimex Biotech, LLC20020—
+2K161480R2 Dermal Cooling SystemR2 Dermatology20165—
+3K171398Dermal Cooling SystemR2 Dermatology,Inc20174—
+4K201260Dermal Cooling SystemR2 Technologies, Inc.20203—
+5K203006R2 Dermabrasion Tip (for Dermal Cooling System)R2 Technologies, Inc.20212—
+6K213294Dermal Cooling SystemR2 Technologies, Inc.20221—
+7K253261Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—