510(k) Report

Devices descending from K123516

7 later devices reach Cryo-Touch IV through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133453IoveraMyoscience, Inc.20146—
+2K142866Myoscience iovera systemMyoscience, Inc.201551
+3K161835iovera systemMyoscience, Inc.20174—
+4K211334Iovera SystemPacira Pharmaceuticals, Inc.20212—
+4K173763iovera systemMyoscience, Inc.20182—
+5K243677iovera° SystemPacira Biosciences, Inc.20240—
+5K220656iovera SystemPacira Biosciences, Inc.20221—