510(k) Report

Devices descending from K070090

5 later devices reach Radiesse Laryngeal Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180631Silk VoiceSofregen Medical, Inc.20181—
+1K121795Calcium Hydroxylapatite Vocal Fold ImplantCytophil, Inc.20130—
+1K081816Vocalis and Vocalis SMCytophil, Inc.20090—
+1K081815Vocalis GelCytophil, Inc.20090—
+2K240919Silk Voice (SMI-04)Sofregen Medical20240—