510(k) Report

Devices descending from K161296

12 later devices reach Cool Renewal through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201740HydrozidMedilink A/S20211—
+1K190747ClaritagDgi Technologies20199—
+2K221897Hydrozid PreciseBibawo Medical A/S20230—
+2K222356Claritag AdvancedDgi Technologies20230—
+2K211099Freeze’n Clear Skin Clinic Warts & TagsCryoconcepts LP20228—
+3K252198Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)Medical Brands Laboratories B.V.20260—
+3K242932Skin Clinic Nitro Clear Wart RemoverCryoconcepts LP20251—
+3K243487CryoFreeze Wart and Skin Tag RemoverCryosurgery, Inc.20251—
+3K242803Compound W Skin Tag RemoverMedtech Products, Inc.20240—
+3K242625Freeze Point & Private Label VersionsCryoconcepts LP20240—
+3K240226Pixie Skin TagOystershell NV20241—
+4K253000CryoFreeze Wart and Skin Tag RemoverCryosurgery, Inc.20250—