510(k) Report

Devices descending from K060395

9 later devices reach Cryo, Model V6.0 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242132FreddoFabinject Lndustria E Comercio Lmportacao E Exportacao Ltda20240—
+1K220020Cryo 7Zimmer Medizinsysteme GmbH20222—
+1K083008CoolskinElbio Co., Ltd.20092—
+1K090618Cynosure Smartcool Family Cold Air Device: Smartcool, Smartcool 6 and Cryo CCynosure, Inc.20090—
+1K080735CryominiZimmer Elektromedizin GmbH20081—
+2K261674Skin Air Cooling System (QALF-01)Beijing Nubway S&T Co., Ltd.20260—
+2K233416Cryojet Plus (SHE-ACP001-1)Beijing Sano Laser S&T Development Co.,Ltd20241—
+2K213294Dermal Cooling SystemR2 Technologies, Inc.20221—
+3K253261Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—